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CN101233408A - Measuring device, measuring apparatus and method of measuring - Google Patents

Measuring device, measuring apparatus and method of measuring Download PDF

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CN101233408A
CN101233408A CNA2006800281738A CN200680028173A CN101233408A CN 101233408 A CN101233408 A CN 101233408A CN A2006800281738 A CNA2006800281738 A CN A2006800281738A CN 200680028173 A CN200680028173 A CN 200680028173A CN 101233408 A CN101233408 A CN 101233408A
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sample
measuring
measuring instrument
supply port
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CN101233408B (en
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福永淳
中南贵裕
龟井明仁
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Panasonic Holdings Corp
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Matsushita Electric Industrial Co Ltd
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Abstract

本发明的测定仪器具有用于保持试剂的第1容器和第2容器、以及用于进行光学测定的光学测定部。第1容器具有用于将含有待测物质的试剂供给至上述第1容器的第1试样供给口和电极。第2容器具有用于将试样供给至上述第2容器的第2试样供给口和用来保持用于光学测定的试剂的试剂保持部。

Figure 200680028173

The measurement device of the present invention has a first container and a second container for holding a reagent, and an optical measurement unit for optical measurement. The first container has a first sample supply port and an electrode for supplying a reagent containing a substance to be measured to the first container. The second container has a second sample supply port for supplying a sample to the second container, and a reagent holding portion for holding a reagent for optical measurement.

Figure 200680028173

Description

测定仪器、测定装置和测定方法 Measuring instrument, measuring device and measuring method

技术领域 technical field

本发明涉及用于分析试样中所含物质的测定仪器及测定方法。The present invention relates to a measuring instrument and a measuring method for analyzing substances contained in a sample.

背景技术 Background technique

一直以来,作为在临床检查领域中使用的测定设备,主要有大规模自动化设备和POCT(即时检验,point of care testing)设备。Conventionally, measurement devices used in the field of clinical examinations mainly include large-scale automated devices and POCT (point of care testing) devices.

上述大规模自动化设备设置于医院的中央临床检查部门或以临床检查委托业务为中心的公司中,其可以对大量患者的检体进行多项目的检查(例如参照专利文献1)。例如日立生产的7170型的大型自动化设备最多可以对36个项目完成每小时800个测试的检查。因此,对检查的效率化起到巨大贡献,可以说是面向具有大量受验者的医院的装置。The above-mentioned large-scale automated equipment is installed in the central clinical examination department of a hospital or a company mainly engaged in clinical examination commissioning business, and it can perform multi-item examinations on samples of a large number of patients (for example, refer to Patent Document 1). For example, the 7170 large-scale automation equipment produced by Hitachi can complete the inspection of 800 tests per hour for 36 items at most. Therefore, it can be said to be a device for hospitals with a large number of subjects, which greatly contributes to the efficiency of examinations.

另一方面,POCT设备是指在除了医院检查室或检察中心之外的医疗现场中所进行的临床检查中使用的设备,也包括家庭医疗中使用的设备(例如参照专利文献2和3)。例如可以举出血糖传感器、妊娠诊断药、排卵检查药、HbAlc/微量白蛋白测定装置(例如Bayer制DCA2000)等。这些POCT设备与大规模自动化设备相比缺乏常用性,但由于可以聚焦于特异于某种病症的标记物质、可以简单且迅速地测定该标记物质,因此在受验者的筛查和监测中是有效的。另外,POCT设备由于小型,因此携带性优异、可以以低成本引入,而且在操作性上也不特别需要专业性,无论是谁都可以使用。On the other hand, POCT equipment refers to equipment used in clinical examinations performed in medical sites other than hospital examination rooms or inspection centers, and also includes equipment used in home medicine (for example, refer to Patent Documents 2 and 3). For example, a blood sugar sensor, a pregnancy diagnosis drug, an ovulation test drug, an HbAlc/microalbumin measuring device (for example, DCA2000 manufactured by Bayer), etc. are mentioned. These POCT devices are less commonly used than large-scale automated devices, but since they can focus on a marker substance specific to a certain disease and measure the marker substance easily and quickly, they are ideal for screening and monitoring of subjects. Effective. In addition, because POCT equipment is small, it is excellent in portability, can be introduced at low cost, and does not require special expertise in operability, so anyone can use it.

目前,存在很多临床检查的测定项目,但当以尿等体液作为检体时,测定方式主要大致分为光学测定方式和电化学测定方式。在上述以往的大规模自动化设备和POCT设备中,分别使用任一测定方式进行测定。Currently, there are many measurement items for clinical examinations, but when a body fluid such as urine is used as a sample, measurement methods are roughly divided into optical measurement methods and electrochemical measurement methods. In the above-mentioned conventional large-scale automated equipment and POCT equipment, any measurement method is used for measurement.

近年来,医疗费用的增高和生活习惯病患者的增多日渐压迫医疗经济,缩减医疗费用和抑制生活习惯病患者增多成为课题。作为该课题的根本解决对策之一,正在研讨以证据为基础的医疗(EBM:Evidencebased-medical,循证医学)。通过进行EBM,可以根据各个患者客观地管理医疗,通过预防医疗的实践,特别期待会抑制生活习惯病患者的数量等。In recent years, the increase in medical expenses and the increase in patients with lifestyle-related diseases have increasingly oppressed the medical economy, and the reduction of medical expenses and the suppression of the increase in patients with lifestyle-related diseases have become issues. As one of the fundamental solutions to this problem, evidence-based medicine (EBM: Evidence-based-medical) is being studied. By performing EBM, medical treatment can be managed objectively according to each patient, and the number of patients with lifestyle-related diseases can be particularly expected to be suppressed through the practice of preventive medicine.

为了确立、实践EBM,利用临床检查得到的检查信息是必不可少的。EBM中的检查信息包括检查结果及根据该结果对患者的解决方法。这里,对患者的解决方法是指饮食管理等生活习惯指导或药物治疗等。即,EBM中的检查的定位是对于要接受医疗的人的“课题的设定”和“方针的决定”。在EBM中,为了更为安心、安全地提供更为充实的解决方法,有必要对要接受医疗的人明确地提出课题。因此,在临床检查中,对于相互具有关系的多个检查项目,重要的是简单、迅速地了解各个检查结果。In order to establish and practice EBM, examination information obtained by clinical examination is essential. Examination information in the EBM includes examination results and solutions for patients based on the results. Here, the solution for the patient refers to lifestyle guidance such as dietary management, drug treatment, and the like. That is, the positioning of examinations in EBM is "setting of tasks" and "determination of policies" for people who are going to receive medical care. In EBM, in order to provide more substantial solutions more securely and safely, it is necessary to clearly raise issues for those who are going to receive medical care. Therefore, in clinical examinations, it is important to easily and quickly understand the respective examination results for a plurality of examination items that are related to each other.

上述现有的大规模自动化设备具有常用性,不管与病症有无关联性,均可进行多个项目的检查。但是,由于装置的构成复杂,因此除了具有专业知识的人之外很难操作,而且,至获得检查结果所需要的时间很长,存在为了向受验者反馈结果所需要的时间很长的问题。另外,上述POCT设备的操作性优异、可以简单且迅速地进行检查,但由于是以与特定病症相关的标记物作为专用的测定设备,因此不能检查多个项目。The above-mentioned existing large-scale automated equipment is commonly used, and can perform inspections of multiple items regardless of whether it is related to a disease. However, due to the complex structure of the device, it is difficult to operate except for persons with specialized knowledge, and it takes a long time to obtain the test result, and there is a problem that it takes a long time to report the result to the test subject. . In addition, the above-mentioned POCT equipment is excellent in operability and can perform inspections easily and quickly. However, since markers related to specific diseases are used as dedicated measurement equipment, multiple items cannot be inspected.

因而,提出了具有试样液通过毛细管作用而流入的空腔且用于生物化学或临床试验的仪器,其具有测定试样的电特性的电极结构和可以释放到空腔内的抗体或酶等试剂,其中空腔的壁是透明的,以便可以对空腔内进行光学测定(例如参照专利文献4)。Therefore, an instrument having a cavity into which a sample solution flows through capillary action and used for biochemical or clinical tests has been proposed, which has an electrode structure for measuring the electrical characteristics of the sample, and antibodies or enzymes that can be released into the cavity. A reagent in which the wall of the cavity is transparent so that optical measurement can be performed in the cavity (for example, refer to Patent Document 4).

专利文献1:日本特开平09-127126号公报Patent Document 1: Japanese Patent Application Laid-Open No. 09-127126

专利文献2:日本特开平07-248310号公报Patent Document 2: Japanese Patent Application Laid-Open No. 07-248310

专利文献3:日本特开平03-046566号公报Patent Document 3: Japanese Patent Application Laid-Open No. 03-046566

专利文献4:美国专利第5141868号说明书Patent Document 4: Specification of US Patent No. 5141868

但是,在专利文献4所记载的仪器的结构中存在下述问题:用于光学测定而使用的试剂通过溶解于供给至空腔内的试样中而到达电极结构,对利用电极结构进行的电特性测定造成不良影响。However, in the structure of the instrument described in Patent Document 4, there is a problem that the reagent used for the optical measurement reaches the electrode structure by dissolving in the sample supplied into the cavity, and the electric current performed by the electrode structure is affected. Detrimental effects on property determination.

发明内容 Contents of the invention

因此,本发明鉴于上述以往的问题点,其目的在于提供具有简单的构成、且可以通过进行试样的光学测定和电化学测定来迅速且正确地测定多个测定项目的测定仪器、测定装置和测定方法。Therefore, in view of the above-mentioned conventional problems, an object of the present invention is to provide a measuring instrument, a measuring device, and a measuring device that have a simple structure and can quickly and accurately measure a plurality of measuring items by optically measuring and electrochemically measuring a sample. test methods.

为了解决上述以往的课题,本发明的测定仪器具备:用于保持含有待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部。In order to solve the above-mentioned conventional problems, the measuring instrument of the present invention includes: a first container and a second container for holding a sample containing a substance to be measured; an optical measurement unit for optical measurement; the first container has a first sample supply port and an electrode for supplying the sample into the first container; the second container has an electrode for supplying the sample to the first container; A sample is supplied to a second sample supply port in the second container and a reagent holding portion for holding a reagent used in the optical measurement.

另外,本发明的测定装置具备:用于安装上述测定仪器的测定仪器安装部;用于发出从所述第2容器的外部入射到内部的入射光的光源;用于接受从所述第2容器的内部射出到外部的出射光的受光部;用于对所述电极施加电压的电压施加部;用于对来自所述电极的电信号进行测定的电信号测定部;和用于基于通过所述受光部接受的所述出射光和通过所述电信号测定部测定的所述电信号中的至少一个来对所述试样中所含的所述待测物质进行检测或定量的运算部。In addition, the measuring device of the present invention includes: a measuring instrument mounting part for mounting the measuring instrument; a light source for emitting incident light from the outside of the second container to the inside; and receiving light from the second container. A light receiving unit for emitting light from the inside to the outside; a voltage applying unit for applying a voltage to the electrodes; an electrical signal measuring unit for measuring electrical signals from the electrodes; A computing unit that detects or quantifies the analyte contained in the sample through at least one of the outgoing light received by the light receiving unit and the electrical signal measured by the electrical signal measuring unit.

另外,本发明的测定方法为使用测定仪器对试样中所含的第1待测物质和第2待测物质进行测定的方法,其中,所述测定仪器具备:用于保持含有第1待测物质和第2待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部,所述测定方法包含以下工序:In addition, the measurement method of the present invention is a method of measuring the first analyte substance and the second analyte substance contained in a sample using a measurement instrument, wherein the measurement instrument is equipped with: a A first container and a second container for a sample of a substance and a second substance to be measured, and an optical measurement unit for optically measuring the sample held in the second container; the first container has a first sample supply port and an electrode for supplying the sample into the first container; the second container has a second sample supply port for supplying the sample into the second container; A sample supply port and a reagent holding part for holding a reagent used in the optical measurement, the measurement method includes the following steps:

(A)将所述试样通过浸渍于所述试样中的所述第1试样供给口供给至所述第1容器内的工序;(A) a step of supplying the sample into the first container through the first sample supply port immersed in the sample;

(B)将所述试样通过浸渍于所述试样中的所述第2试样供给口供给至所述第2容器内的工序;(B) a step of supplying the sample into the second container through the second sample supply port immersed in the sample;

(C)对所述电极施加电压的工序;(C) a step of applying a voltage to the electrodes;

(D)对来自所述电极的电信号进行测定的工序;(D) a step of measuring electrical signals from the electrodes;

(E)基于在所述工序(D)中测定的所述电信号来对所述第2待测物质进行检测或定量的工序;(E) a step of detecting or quantifying the second analyte based on the electrical signal measured in the step (D);

(F)将入射光通过所述光学测定部照射到保持于所述第2容器内的所述试样上的工序;(F) a step of irradiating incident light onto the sample held in the second container through the optical measurement unit;

(G)对由于所述入射光的照射而引起的从所述第2容器的内部通过所述光学测定部射出到外部的出射光进行测定的工序;(G) a step of measuring emitted light emitted from the inside of the second container through the optical measurement unit to the outside due to the irradiation of the incident light;

(H)基于在所述工序(G)中测定的所述出射光来对所述第1待测物质进行检测或定量的工序。(H) A step of detecting or quantifying the first analyte substance based on the emitted light measured in the step (G).

根据本发明,可以提供通过进行试样的光学测定和电化学测定,能够对多个测定项目迅速且正确地进行测定的测定仪器、测定装置和测定方法。According to the present invention, it is possible to provide a measuring instrument, a measuring device, and a measuring method capable of rapidly and accurately measuring a plurality of measurement items by performing optical measurement and electrochemical measurement of a sample.

附图说明 Description of drawings

图1为表示本发明的一个实施方式的测定仪器的立体图。FIG. 1 is a perspective view showing a measuring instrument according to one embodiment of the present invention.

图2为同一测定仪器的图1的A-A剖面图。Fig. 2 is an A-A sectional view of Fig. 1 of the same measuring instrument.

图3为同一测定仪器的分解立体图。Fig. 3 is an exploded perspective view of the measuring instrument.

图4为表示同一实施方式的测定装置的立体图。Fig. 4 is a perspective view showing a measurement device of the same embodiment.

图5为表示同一测定装置的构成的模块图。Fig. 5 is a block diagram showing the configuration of the measuring device.

图6为表示同一实施方式的测定仪器的变形例的立体图。Fig. 6 is a perspective view showing a modified example of the measuring instrument of the same embodiment.

图7为同一测定仪器的图6的B-B剖面图。Fig. 7 is a B-B sectional view of Fig. 6 of the same measuring instrument.

图8为表示本发明的另一实施方式的测定仪器的立体图。Fig. 8 is a perspective view showing a measuring instrument according to another embodiment of the present invention.

图9为同一测定仪器的图8的C-C剖面图。Fig. 9 is a C-C sectional view of Fig. 8 of the same measuring instrument.

图10为同一测定仪器的分解立体图。Fig. 10 is an exploded perspective view of the measuring instrument.

图11为表示同一实施方式的测定装置的立体图。Fig. 11 is a perspective view showing a measurement device of the same embodiment.

图12为表示同一实施方式的测定仪器的变形例的分解立体图。Fig. 12 is an exploded perspective view showing a modified example of the measuring instrument of the same embodiment.

图13为表示同一实施方式的测定仪器的其它变形例的立体图。Fig. 13 is a perspective view showing another modified example of the measuring instrument of the same embodiment.

图14为表示同一实施方式的测定仪器的其它变形例的图13的D-D剖面图。Fig. 14 is a sectional view taken along line D-D of Fig. 13 showing another modified example of the measuring instrument of the same embodiment.

图15为本发明的又一实施方式的测定仪器的变形例的立体图。Fig. 15 is a perspective view of a modified example of the measurement device according to still another embodiment of the present invention.

图16为同一测定仪器的图15的E-E剖面图。Fig. 16 is an E-E sectional view of Fig. 15 of the same measuring instrument.

图17为同一测定仪器的俯视图。Fig. 17 is a plan view of the same measuring instrument.

图18为同一测定仪器的分解立体图。Fig. 18 is an exploded perspective view of the measuring instrument.

图19为表示同一测定仪器的阀打开的状态的要部剖面图。Fig. 19 is a cross-sectional view of main parts showing a state in which the valve of the measuring instrument is opened.

图20为表示同一实施方式的测定装置的立体图。Fig. 20 is a perspective view showing a measurement device of the same embodiment.

图21为表示同一测定装置的构成的模块图。Fig. 21 is a block diagram showing the configuration of the measuring device.

具体实施方式 Detailed ways

本发明的测定仪器具备:用于保持试样的第1容器和第2容器、以及用于对保持于所述第2容器内的所述试样进行光学测定的光学测定部,所述第1容器具备用于将试样供给至所述第1容器内的第1试样供给口及电极,所述第2容器具备用于将试样供给至所述第2容器内的第2试样供给口及用来保持用于所述光学测定的试剂的试剂保持部。The measuring instrument of the present invention includes: a first container and a second container for holding a sample, and an optical measurement unit for optically measuring the sample held in the second container, the first The container includes a first sample supply port and an electrode for supplying a sample into the first container, and the second container includes a second sample supply port for supplying a sample into the second container. A mouth and a reagent holding part for holding a reagent used in the optical measurement.

通过这种构成,可以通过将试样1次供给至第1容器和第2容器内、使用1个测定仪器来进行试样的光学测定和电化学测定。通过设置第1容器和第2容器、在第1容器内设置电极、在第2容器内设置用于光学测定的试剂,则光学测定所需要的试剂不会扩散至电极、不会对电化学测定造成影响,因此可以迅速且正确地测定多个测定项目。With this configuration, the optical measurement and the electrochemical measurement of the sample can be performed by supplying the sample into the first container and the second container at one time and using one measuring instrument. By arranging the first container and the second container, placing electrodes in the first container, and placing reagents for optical measurement in the second container, the reagents required for optical measurement will not diffuse to the electrodes and will not affect the electrochemical measurement. Because of the influence, it is possible to quickly and accurately measure a plurality of measurement items.

这里,优选上述第1试样供给口和上述第2试样供给口设置在相互邻接的位置上。其原因在于,根据这种构成,易于将同一试样供给至第1容器和第2容器。Here, it is preferable that the first sample supply port and the second sample supply port are provided at positions adjacent to each other. This is because, with such a configuration, it is easy to supply the same sample to the first container and the second container.

另外,上述光学测定部优选具备用于使入射光从上述第2容器的外部入射到内部的光入射部、和用于使出射光从上述第2容器的内部射出到外部的光出射部。In addition, the optical measuring unit preferably includes a light incident unit for allowing incident light to enter from the outside of the second container to the inside, and a light emitting unit for emitting emitted light from the inside to the outside of the second container.

这种光入射部和光出射部优选由光学透明的材料或基本上不具有可见光吸收的材料来形成。例如可以举出石英、玻璃或者聚苯乙烯、聚甲基丙烯酸甲酯等。当将仪器做成一次性的时,从成本的观点出发,优选聚苯乙烯。Such a light entrance portion and a light exit portion are preferably formed of an optically transparent material or a material substantially not absorbing visible light. For example, quartz, glass, polystyrene, polymethylmethacrylate, etc. are mentioned. When making the device disposable, polystyrene is preferred from the viewpoint of cost.

另外,上述电极优选为一对电极。根据这种构成,例如通过测定试样的电导率,可以了解试样中所含的盐的浓度。In addition, the above-mentioned electrodes are preferably a pair of electrodes. According to this configuration, for example, by measuring the electrical conductivity of the sample, the concentration of the salt contained in the sample can be known.

作为电极的材料,优选至少含有金、铂、钯或它们的合金或混合物及碳中的至少一个的材料。这些材料在化学、电化学方面是稳定的,可以实现稳定的测定。As the material of the electrode, a material containing at least one of gold, platinum, palladium, or an alloy or mixture thereof, and carbon is preferable. These materials are chemically and electrochemically stable, enabling stable measurement.

另外,上述电极优选为用于测定试样中所含的特定化合物或离子浓度的电极。根据这种构成,可以了解试样中的特定化合物的浓度。例如使用玻璃电极等时,可以测定钠离子的浓度。In addition, the above-mentioned electrode is preferably an electrode for measuring the concentration of a specific compound or ion contained in a sample. Based on this configuration, the concentration of a specific compound in a sample can be known. For example, when a glass electrode or the like is used, the concentration of sodium ions can be measured.

而且,上述电极优选为具有感应试样中所含的特定离子的膜(离子感应膜)的电极。根据这种构成,可以了解试样中的特定离子的浓度。Furthermore, the electrode is preferably an electrode having a membrane (ion-sensitive membrane) that senses specific ions contained in a sample. According to this configuration, the concentration of specific ions in the sample can be known.

这里,离子感应膜可以使用具有使钠离子、钾离子、锂离子、镁离子、钙离子、氯化物离子、铵离子、氢离子等离子中的任一个选择性地透过的功能的膜。Here, as the ion-sensitive membrane, a membrane having a function of selectively permeating any one of sodium ions, potassium ions, lithium ions, magnesium ions, calcium ions, chloride ions, ammonium ions, and hydrogen ions can be used.

构成离子感应膜的化合物可以根据想要透过的离子使用公知的化合物。例如可以使用下述具有离子选择性的包合物:为钠离子时,可以使用双[(12-冠-4)甲基]2,2-二苯并丙二酸酯等;为钾离子时,可以使用双[(苯并5-冠-5)4-甲基]庚二酸酯等;为锂离子时,可以使用磷酸十二烷基-14-冠-4等;为镁离子时,可以使用4,13-双[N-(1-金刚烷基)氨甲酰基乙酰基]-8-十四烷基-1,7,10,16-四氧杂-4,13-二氮杂环十八烷等;为钙离子时,可以使用4,16-双(N-十八烷基氨甲酰基)-3-八丁酰基(octbutyryl)-1,7,10,13,19-五氧杂-4,16-二氮杂环二十一烷等;为氯化合物离子时,可以使用2,7-二叔丁基-9,9-二甲基-4,5-双(N-正丁基亚硫脲基)呫吨等;为铵离子时,可以使用2,6,13,16,23,26-六氧杂七环[25.4.4.47,12.417,22.O1,17.O7,12.O17,22]四十三烷等。上述包合物均可以作为市售品从例如同仁化学研究所株式会社获得。As the compound constituting the ion-sensitive membrane, known compounds can be used depending on the ions to be permeated. For example, the following clathrates with ion selectivity can be used: when it is a sodium ion, bis[(12-crown-4)methyl]2,2-dibenzomalonate, etc. can be used; when it is a potassium ion , can use bis[(benzo5-crown-5)4-methyl]pimelate etc.; when it is lithium ion, can use phosphate dodecyl-14-crown-4 etc.; when it is magnesium ion, 4,13-bis[N-(1-adamantyl)carbamoylacetyl]-8-tetradecyl-1,7,10,16-tetraoxa-4,13-diazepine can be used Cyclooctadecane, etc.; for calcium ions, 4,16-bis(N-octadecylcarbamoyl)-3-octabutyryl (octbutyryl)-1,7,10,13,19-pentaoxo can be used Hetero-4,16-diazacyclohexadecane, etc.; when it is a chloride compound ion, 2,7-di-tert-butyl-9,9-dimethyl-4,5-bis(N-normal Butylthioureido) xanthene, etc.; when it is ammonium ion, 2,6,13,16,23,26-hexaoxacycline [25.4.4.4 7,12 .4 17,22 .O 1 , 17 .O 7, 12 .O 17 , 22 ] Tetratricosane, etc. All of the above clathrates can be obtained as commercial items from Dojin Chemical Laboratory Co., Ltd., for example.

作为在电极上形成离子感应膜的方法,例如有下述方法:将上述包合物、增塑剂、阴离子排除剂、PVC等高分子化合物溶解于有机溶剂,将所得混合溶液涂覆在电极上并通过风干等使其干燥。As a method of forming an ion-sensitive membrane on an electrode, for example, there is a method of dissolving the above-mentioned clathrate, plasticizer, anion excluder, PVC and other polymer compounds in an organic solvent, and coating the resulting mixed solution on the electrode. And make it dry by air drying etc.

上述电极也可以是通过硅等形成的场效应型晶体管(FET)的电极。另外,优选使用电位稳定的参比电极、例如Ag/AgCl或饱和甘汞电极作为一个电极,或作为第三电极与其它电极组合使用。The above-mentioned electrode may be an electrode of a field effect transistor (FET) formed of silicon or the like. In addition, it is preferred to use a potential-stabilized reference electrode, such as Ag/AgCl or a saturated calomel electrode, as one electrode, or as a third electrode in combination with other electrodes.

另外,优选在电极上附载有酶。由于酶高选择性地催化特定化合物的反应,因此可以实现对试样中特定化合物选择性高的测定。根据成为测定对象的化合物,从选择性、反应性的观点出发,可以使用以往公知的最合适的酶。In addition, it is preferable to carry an enzyme on the electrode. Since the enzyme catalyzes the reaction of a specific compound with high selectivity, it is possible to achieve a highly selective determination of a specific compound in a sample. Depending on the compound to be measured, conventionally known most suitable enzymes can be used from the viewpoint of selectivity and reactivity.

作为酶的例子,可以举出葡糖氧化酶、葡糖脱氢酶、醇氧化酶、胆固醇氧化酶等。这些酶可以购买市售品而获得。Examples of enzymes include glucose oxidase, glucose dehydrogenase, alcohol oxidase, cholesterol oxidase and the like. These enzymes can be purchased as commercially available products.

本发明中,酶优选不溶于试样而固定在电极上。根据这种构成,即便试样的量不均,也可以进行精度良好的测定。In the present invention, the enzyme is preferably insoluble in the sample and immobilized on the electrode. According to this configuration, even if the amount of the sample is not uniform, it is possible to perform accurate measurement.

另外,还可以根据需要使用可以进行酶和电极间的电子输送的电子传递体、例如铁/亚铁氰化物离子、二茂铁衍生物、钌络合物、锇络合物或醌衍生物等。将酶固定在电极上时,更优选将电子传递体也一并固定。In addition, electron mediators capable of electron transport between the enzyme and the electrode, such as iron/ferrocyanide ions, ferrocene derivatives, ruthenium complexes, osmium complexes, or quinone derivatives, can also be used as needed. . When the enzyme is immobilized on the electrode, it is more preferable to also immobilize the electron carrier.

另外,上述电极优选设置在第1容器内与从测定仪器的外部入射到内部的入射光和从测定仪器的内部射出到外部的出射光的光路不同的位置上。In addition, the electrode is preferably provided in the first container at a position different from the optical path of the incident light from the outside to the inside of the measuring instrument and the outgoing light from the inside of the measuring instrument to the outside.

根据这种构成,电极不会遮挡入射光和出射光,另外,由于在第2容器内未设置电极,因此对于供给至第2容器内的试样可以进行良好的光学测定。According to this configuration, the electrodes do not block incident light and outgoing light, and since no electrodes are provided in the second container, good optical measurement can be performed on the sample supplied into the second container.

本发明的测定仪器进一步优选试剂含有酶或抗体。试剂优选按照按照下述方式进行配置:以干燥状态包含在第2容器内,当将试样供给至第2容器内时,溶解于试样中。In the measurement device of the present invention, it is further preferable that the reagent contains an enzyme or an antibody. The reagent is preferably arranged so that it is contained in the second container in a dry state, and is dissolved in the sample when the sample is supplied into the second container.

例如,可以将由玻璃纤维或滤纸等构成的多孔性载体含浸于试剂的溶液后使其干燥,从而使试剂附载,并将该多孔性的载体设置在第2容器内。另外,还可以将试剂的溶液直接涂布在构成第2容器的壁面上后进行干燥,从而配置试剂。For example, the reagent can be supported by impregnating a porous carrier made of glass fiber or filter paper in a solution of the reagent and then drying it, and the porous carrier can be placed in the second container. In addition, the reagent solution may be directly applied to the wall surface constituting the second container, followed by drying to arrange the reagent.

作为试剂的抗体由于可以通过公知的方法产生,因此从易于制作试剂的方面出发是有利的。例如,通过将白蛋白等蛋白、hCG、LH等激素作为抗原,对小鼠、兔子等免疫,可以获得对上述抗原的抗体。Antibodies as reagents are advantageous in terms of ease of preparation of reagents because they can be produced by known methods. For example, antibodies against the above-mentioned antigens can be obtained by immunizing mice, rabbits, etc., with proteins such as albumin and hormones such as hCG and LH as antigens.

作为抗体,可以举出对白蛋白等尿中所含蛋白的抗体、对hCG、LH等尿中所含激素的抗体等。根据需要还可以使促进抗原和抗体的凝集反应的聚乙二醇等化合物共存在测定仪器内的抗体附近。Examples of antibodies include antibodies against proteins contained in urine such as albumin, antibodies against hormones such as hCG and LH contained in urine, and the like. If necessary, a compound such as polyethylene glycol, which promotes the agglutination reaction of the antigen and the antibody, may coexist near the antibody in the measuring device.

作为试剂的酶由于高选择性地催化特定的化合物反应,因此可以实现对试样中特定的化合物选择性高的测定。根据成为测定对象的化合物,从选择性、反应性的观点出发,可以使用以往公知的最合适的酶。Since the enzyme as a reagent catalyzes the reaction of a specific compound with high selectivity, it is possible to achieve a highly selective measurement of a specific compound in a sample. Depending on the compound to be measured, conventionally known most suitable enzymes can be used from the viewpoint of selectivity and reactivity.

作为酶的例子,可以举出葡糖氧化酶、葡糖脱氢酶、醇氧化酶、胆固醇氧化酶或其它氧化还原酶等。此时,当使酶反应的结果显色或消色的色素或色素源与酶共存时,光学测定稳定。这些酶可以购买市售品而获得。Examples of enzymes include glucose oxidase, glucose dehydrogenase, alcohol oxidase, cholesterol oxidase, and other oxidoreductases. In this case, optical measurement is stable when a dye or a dye source that causes the result of the enzyme reaction to develop or decolorize coexists with the enzyme. These enzymes can be purchased as commercially available products.

另外,本发明的测定装置具备:用于安装上述测定仪器的测定仪器安装部;用于发出入射到所述测定仪器的所述第2容器内的入射光的光源;用于接受从所述第2容器射出的出射光的受光部;用于对所述电极施加电压的电压施加部;用于对来自所述电极的电信号进行测定的电信号测定部;和用于基于通过所述受光部接受的所述出射光和通过所述电信号测定部测定的所述电信号中的至少一个来对试样中所含的待测物质进行检测或定量的运算部。In addition, the measuring device of the present invention includes: a measuring instrument mounting part for mounting the measuring instrument; a light source for emitting incident light into the second container of the measuring instrument; 2. A light receiving unit for emitting light emitted from the container; a voltage applying unit for applying a voltage to the electrodes; an electrical signal measuring unit for measuring electrical signals from the electrodes; A computing unit that detects or quantifies a substance to be measured contained in a sample by receiving at least one of the emitted light and the electrical signal measured by the electrical signal measuring unit.

这里,上述测定仪器优选以可以装卸的状态安装在上述测定装置中。另外,测定仪器优选一次性使用。Here, it is preferable that the measuring device is attached to the measuring device in a detachable state. In addition, the measuring instrument is preferably used once.

另外,本发明的测定装置优选进一步具备抽吸部,该抽吸部用于通过抽吸将上述试样供给至安装于上述测定仪器安装部的上述测定仪器的上述第1容器和上述第2容器中的至少一个。In addition, the measuring device of the present invention preferably further includes a suction unit for supplying the sample by suction to the first container and the second container of the measuring instrument attached to the measuring instrument mounting portion. at least one of the

这里,上述测定仪器优选进一步具有用于将试样抽吸至第1容器和/或第2容器内的抽吸口。根据这种构成,在按照测定仪器的抽吸口连接于测定仪器安装部的方式来安装测定仪器的状态下,使用抽吸部,可以容易地将试样供给至测定仪器的第1容器和/或第2容器内。Here, the measuring instrument preferably further has a suction port for sucking the sample into the first container and/or the second container. According to this structure, in the state where the measuring instrument is mounted so that the suction port of the measuring instrument is connected to the measuring instrument mounting part, the sample can be easily supplied to the first container and/or the measuring instrument using the suction part. or in the second container.

在上述仪器中,可以将第1抽吸口设置在第1容器中,将第2抽吸口设置在第2容器中。此时,优选将第1抽吸口和第2抽吸口设置在相互邻接的位置上。In the above apparatus, the first suction port may be provided in the first container, and the second suction port may be provided in the second container. At this time, it is preferable to provide the first suction port and the second suction port at positions adjacent to each other.

根据这种构成,通过将测定仪器安装在单一的测定仪器安装部,可以使用抽吸部,分别将试样同时通过第1抽吸口和第2抽吸口抽吸至第1容器和第2容器内。According to this configuration, by attaching the measuring instrument to the single measuring instrument mounting part, the suction part can be used to simultaneously suck the sample into the first container and the second suction port through the first suction port and the second suction port respectively. inside the container.

抽吸部可以是手动的也可以是自动的,例如可以举出与以往的注射器、分配器等同样的活塞机构。The suction unit may be manual or automatic, and examples thereof include the same piston mechanism as conventional syringes, dispensers, and the like.

在这些活塞机构中,使活塞工作的方法可以是手动的,也可以是自动的,由于自动化可以减轻操作者的负担,因此优选。作为自动化的方法,有利用电动机使活塞工作的方法。作为电动机,有步进电动机、直流电动机等。In these piston mechanisms, the method of operating the piston may be manual or automatic, but automation is preferable because it can reduce the burden on the operator. As an automated method, there is a method of operating a piston using an electric motor. As the motor, there are stepping motors, DC motors, and the like.

步进电动机是每输入1个脉冲信号则旋转特定旋转角的电动机,由于可以通过脉冲数决定旋转角度,因此不需要用于定位的编码器。即,可以通过输入脉冲数来控制活塞的工作距离。A stepping motor is a motor that rotates by a specific rotation angle every time a pulse signal is input, and since the rotation angle can be determined by the number of pulses, an encoder for positioning is not required. That is, the working distance of the piston can be controlled by inputting the number of pulses.

电动机的旋转运动通过使用组合了齿轮机构、阳螺纹和阴螺纹的直线机构等转换为直线运动,从而使活塞工作。为直流电动机的情况下,将旋转运动转变为直线运动的方法也是同样的,但为直流电动机时,为了控制活塞的工作距离,检测电动机的旋转位置的编码器是必要的。另外,也有线性的步进电动机,该类型的电动机在电动机中组装有组合了阳螺纹和阴螺纹的直线机构,成为根据输入脉冲数、棒状的可动部进行直线运动的构成。因此,可以在该棒上直接连接活塞,结构变得简单。The rotary motion of the motor is converted into linear motion by using a gear mechanism, a linear mechanism combining male and female threads, etc., thereby operating the piston. In the case of a DC motor, the method of converting rotary motion into linear motion is the same, but in the case of a DC motor, an encoder for detecting the rotational position of the motor is necessary to control the working distance of the piston. In addition, there is also a linear stepping motor. In this type of motor, a linear mechanism combining a male screw and a female screw is incorporated into the motor, and the rod-shaped movable part performs linear motion according to the number of input pulses. Therefore, the piston can be directly connected to the rod, and the structure becomes simple.

另外,例如在将试样供给至测定仪器的第2容器时可以使用上述抽吸部,在将试样供给至第1容器时可以利用毛细管现象。此时,优选使构成第1容器的部件的内表面为亲水性。根据这种构成,可以顺畅、均匀或迅速地将试样供给至第1容器。In addition, for example, the above-mentioned suction unit can be used when supplying the sample to the second container of the measuring instrument, and capillary phenomenon can be utilized when supplying the sample to the first container. At this time, it is preferable to make the inner surface of the member constituting the first container hydrophilic. According to this configuration, the sample can be supplied to the first container smoothly, uniformly, or quickly.

另外,本发明的测定方法为使用测定仪器对试样中所含的第1待测物质和第2待测物质进行测定的方法,其中,所述测定仪器具备:用于保持含有第1待测物质和第2待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部,所述测定方法包含以下工序:In addition, the measurement method of the present invention is a method of measuring the first analyte substance and the second analyte substance contained in a sample using a measurement instrument, wherein the measurement instrument is equipped with: a A first container and a second container for a sample of a substance and a second substance to be measured, and an optical measurement unit for optically measuring the sample held in the second container; the first container has a first sample supply port and an electrode for supplying the sample into the first container; the second container has a second sample supply port for supplying the sample into the second container; A sample supply port and a reagent holding part for holding a reagent used in the optical measurement, the measurement method includes the following steps:

(A)将所述试样通过浸渍于所述试样中的所述第1试样供给口供给至所述第1容器内的工序;(A) a step of supplying the sample into the first container through the first sample supply port immersed in the sample;

(B)将所述试样通过浸渍于所述试样中的所述第2试样供给口供给至所述第2容器内的工序;(B) a step of supplying the sample into the second container through the second sample supply port immersed in the sample;

(C)对所述电极施加电压的工序;(C) a step of applying a voltage to the electrodes;

(D)对来自所述电极的电信号进行测定的工序;(D) a step of measuring electrical signals from the electrodes;

(E)基于在所述工序(D)中测定的所述电信号来对所述第2待测物质进行检测或定量的工序;(E) a step of detecting or quantifying the second analyte based on the electrical signal measured in the step (D);

(F)将入射光通过所述光学测定部照射到保持于所述第2容器内的所述试样上的工序;(F) a step of irradiating incident light onto the sample held in the second container through the optical measurement unit;

(G)对由于所述入射光的照射而引起的从所述第2容器的内部通过所述光学测定部射出到外部的出射光进行测定的工序;(G) a step of measuring emitted light emitted from the inside of the second container through the optical measurement unit to the outside due to the irradiation of the incident light;

(H)基于在所述工序(G)中测定的所述出射光来对所述第1待测物质进行检测或定量的工序。(H) A step of detecting or quantifying the first analyte substance based on the emitted light measured in the step (G).

这里,本发明的测定仪器中,优选按照从所述第2试样供给口至所述试剂保持部的距离X与从所述第1试样供给口至所述电极的距离Y满足关系式X<Y的方式来配置所述试剂保持部和所述电极。而且,优选在所述工序(D)中检测所述电信号的变化,并基于所述检测自动地进行所述工序(F)。Here, in the measuring instrument of the present invention, it is preferable that the distance X from the second sample supply port to the reagent holding part and the distance Y from the first sample supply port to the electrode satisfy the relational expression X The reagent holding part and the electrodes are arranged in a manner <Y. Furthermore, it is preferable to detect a change in the electrical signal in the step (D), and to automatically perform the step (F) based on the detection.

根据这种构成,由第1试样供给口和第2试样供给口供给的试样比电极更早地到达试剂保持部。因而,通过检测来自电极的电信号变化,感知试样到达电极,基于该检测,自动地向试样照射入射光,则可以防止由于试样不足而在试剂溶解于试样之前错误地进行光学测定。According to this configuration, the sample supplied from the first sample supply port and the second sample supply port reaches the reagent holding portion earlier than the electrodes. Therefore, by detecting the change of the electrical signal from the electrode, sensing the arrival of the sample at the electrode, and automatically irradiating incident light to the sample based on the detection, it is possible to prevent erroneous optical measurement before the reagent dissolves in the sample due to insufficient sample. .

另外,在测定仪器中,第1容器还可以进一步具有空气孔。空气孔优选设置在挟持电极且位于与第1试样供给口相反侧的部分上。根据该构成,第1容器作为空腔(毛细管)发挥功能,试样通过毛细管现象从第1试样供给口供给至电极。因此,仅通过使第1试样供给口与试样相接触,就可以容易地将试样供给至第1容器内。In addition, in the measuring instrument, the first container may further have air holes. The air hole is preferably provided in a portion that sandwiches the electrode and is located on the opposite side to the first sample supply port. According to this configuration, the first container functions as a cavity (capillary), and the sample is supplied from the first sample supply port to the electrode by capillary action. Therefore, the sample can be easily supplied into the first container only by bringing the first sample supply port into contact with the sample.

另外,优选上述第1试样供给口和上述第2试样供给口设置在相互邻接的位置上,在上述工序(D)中检测上述电信号的变化,并基于上述检测,在上述工序(B)中将上述试样通过上述第2试样供给口抽吸至上述第2容器内。In addition, it is preferable that the above-mentioned first sample supply port and the above-mentioned second sample supply port are provided at positions adjacent to each other, the change of the electric signal is detected in the above-mentioned step (D), and based on the above-mentioned detection, in the above-mentioned step (B) ), the sample is sucked into the second container through the second sample supply port.

根据这种构成,通过在电极中检测电信号的变化,可以感知测定仪器的第1试样供给口和第2试样供给口已浸渍在试样中,因此可以防止在第2试样供给口浸渍于试样中之前错误地进行试样的抽吸。According to this structure, by detecting the change of the electrical signal in the electrode, it can be sensed that the first sample supply port and the second sample supply port of the measuring instrument have been immersed in the sample, so it is possible to prevent the second sample supply port from being immersed in the sample. Incorrect suction of the sample before immersion in the sample.

另外,本发明的测定仪器中,上述第1容器和上述第2容器可以介由上述第2试样供给口来相互连通。此时,优选进一步具有防止上述试样从上述第2容器通过上述第2试样供给口流入到上述第1容器的阀。In addition, in the measuring instrument of the present invention, the first container and the second container may communicate with each other via the second sample supply port. In this case, it is preferable to further include a valve for preventing the sample from flowing from the second container into the first container through the second sample supply port.

这里,进一步优选基于第1待测物质的定量结果和第2待测物质的定量结果的任何一个来校正另一个的定量结果。Here, it is further preferable to correct the quantitative result of the other based on any one of the quantitative result of the first analyte substance and the quantitative result of the second analyte substance.

这样,通过对相互有关的多个检查项目进行测定,可以提高测定结果的精度。In this way, by measuring a plurality of inspection items related to each other, the accuracy of the measurement results can be improved.

作为本发明中的试样,可以举出血清、血浆、血液、尿、组织间液或淋巴液等体液,培养基的上清液等液体试样。或者,还可以将与上述体液中的特定成分发生反应的试剂、例如酶、抗体或色素等与体液混合后作为试样供给至测定仪器。Examples of the sample in the present invention include body fluids such as serum, plasma, blood, urine, interstitial fluid, and lymph fluid, and liquid samples such as culture supernatant. Alternatively, a reagent that reacts with a specific component in the above-mentioned body fluid, such as an enzyme, an antibody, or a pigment, may be mixed with the body fluid and supplied as a sample to a measuring device.

其中,优选尿作为试样。当试样为尿时,可以无创地进行家庭中的日常健康管理。Among them, urine is preferable as the sample. When the sample is urine, daily health management at home can be performed noninvasively.

作为第1待测物质,可以举出白蛋白、hCG、LH、CRP、IgG等。另外,作为第2待测物质,可以举出钠离子、钾离子、锂离子、镁离子、钙离子、氯化物离子、铵离子、氢离子、葡萄糖等。Examples of the first sample substance include albumin, hCG, LH, CRP, IgG, and the like. In addition, examples of the second sample substance include sodium ions, potassium ions, lithium ions, magnesium ions, calcium ions, chloride ions, ammonium ions, hydrogen ions, glucose, and the like.

在健康管理的最初阶段进行的尿的定性检查中,对pH、比重、蛋白、糖、潜血、酮体、胆红素、尿胆素原、亚硝酸盐、白血球、抗坏血酸、淀粉酶、食盐这12个项目进行检查。另外,以分析肾功能为目的有微量白蛋白,作为妊娠检查、排卵检查等的标记物,有hCG、LH等激素。In the qualitative examination of urine at the initial stage of health management, pH, specific gravity, protein, sugar, occult blood, ketone body, bilirubin, urobilinogen, nitrite, leukocyte, ascorbic acid, amylase, salt, etc. 12 items are checked. In addition, there is microalbumin for the purpose of analyzing renal function, and hormones such as hCG and LH are used as markers for pregnancy tests, ovulation tests, and the like.

对这些检查项目大致分类,则蛋白、微量白蛋白、hCG、LH等激素适于基于抗原抗体反应的光学测定。作为基于抗原抗体反应的光学测定,可以举出免疫浊度法、免疫比浊法、胶乳免疫凝集法等对基于抗原抗体反应而在试样中产生的混浊进行测定的方法。Roughly classifying these inspection items, hormones such as protein, microalbumin, hCG, and LH are suitable for optical measurement based on antigen-antibody reactions. Examples of optical measurements based on antigen-antibody reactions include immunoturbidimetry, immunoturbidimetry, latex immunoagglutination, and other methods for measuring turbidity generated in a sample by antigen-antibody reactions.

另一方面,尿中的盐分(钠离子、钾离子)、pH、糖等主要是基于电化学测定来进行测定。特别是尿中的糖分或盐分是反应饮食等生活习惯的物质,是用于提出与健康管理相关的解决方法的重要信息。On the other hand, the salt content (sodium ion, potassium ion), pH, sugar, etc. in urine are mainly measured based on electrochemical measurement. In particular, sugar and salt in urine are substances that reflect lifestyle habits such as diet, and are important information for proposing solutions related to health management.

盐分和pH会影响抗原抗体反应。例如,由于高盐浓度状态的抗原抗体反应的解离性强、反应量减少,因此会带来负的测定误差。尿中的盐分和pH由于有日内变动、日间变动、个体差异,因此难以预测所产生的误差。但是,通过电化学测定获得盐分值或pH值,并将在光学测定中表示各种盐分浓度或pH值的出射光强度和抗原浓度的关系的数据作为校准曲线进行参照,可以校正抗原浓度的测定误差。Salt and pH affect antigen-antibody responses. For example, the dissociation of the antigen-antibody reaction in the state of high salt concentration is strong and the reaction volume is reduced, which causes a negative measurement error. Since the salt content and pH in urine have intraday fluctuations, diurnal fluctuations, and individual differences, it is difficult to predict the resulting errors. However, the difference in antigen concentration can be corrected by obtaining the salt value or pH value by electrochemical measurement, and referring to the data showing the relationship between the outgoing light intensity and the antigen concentration at various salt concentrations or pH values in optical measurement as a calibration curve. Measurement error.

以下参照附图说明本发明的优选实施方式。另外,在以下的说明中,相同或相当的部分带有相同符号,有时省略重复的说明。Preferred embodiments of the present invention will be described below with reference to the drawings. In addition, in the following description, the same or corresponding part is attached|subjected with the same code|symbol, and the overlapping description may be abbreviate|omitted.

[实施方式1][Embodiment 1]

1.测定仪器1. Measuring instrument

以下使用附图详细地说明本发明的测定仪器的一个实施方式。这里,对试样为尿、第1待测物质为人白蛋白、第2待测物质为葡萄糖的情况进行说明。One embodiment of the measurement device of the present invention will be described in detail below using the drawings. Here, a case where the sample is urine, the first test substance is human albumin, and the second test substance is glucose will be described.

首先,使用图1~3说明本实施方式的测定仪器的结构。图1为表示本发明的测定仪器的一个实施方式的立体图,图2为图1的A-A剖面图。图3为图1和图2所示的本发明的测定仪器的分解立体图。First, the configuration of the measurement device according to the present embodiment will be described using FIGS. 1 to 3 . FIG. 1 is a perspective view showing one embodiment of a measuring instrument of the present invention, and FIG. 2 is a sectional view taken along line A-A of FIG. 1 . Fig. 3 is an exploded perspective view of the measuring instrument of the present invention shown in Figs. 1 and 2 .

本实施方式的测定仪器100具有沿着箭头P方向的长度,具备透明聚苯乙烯制的第1部件101、第2部件102和第3部件103。The measuring instrument 100 of the present embodiment has a length along the arrow P direction, and includes a first member 101 , a second member 102 , and a third member 103 made of transparent polystyrene.

通过组合第1部件101和第3部件103,形成两端开放的空间,该空间部分作为第1容器104发挥功能。而且,作为第1容器104发挥功能的空间的一个开放端作为第1试样供给口105发挥功能,另一个开放端作为第1抽吸口106发挥功能。By combining the first member 101 and the third member 103 , a space with open ends is formed, and this space part functions as the first container 104 . Furthermore, one open end of the space functioning as the first container 104 functions as the first sample supply port 105 , and the other open end functions as the first suction port 106 .

另外,在第3部件103上设置有一对导电部。而且,在一对导电部上按照一对电极201a、202a和一对连接部201b、202b露出至第1容器104内的方式而设置有由绝缘性树脂构成的盖子203(参照图3)。In addition, a pair of conductive parts are provided on the third member 103 . Furthermore, a cover 203 made of insulating resin is provided on the pair of conductive parts so that the pair of electrodes 201a, 202a and the pair of connection parts 201b, 202b are exposed into the first container 104 (see FIG. 3 ).

而且,同样地,通过组合第2部件102和第3部件103,形成两端开放的空间,该空间部分作为第2容器107发挥功能。而且,作为第2容器107发挥功能的空间的一个开放端作为第2试样供给口108发挥功能,另一个开放端作为第2抽吸口109发挥功能。Furthermore, similarly, by combining the second member 102 and the third member 103 , a space with both ends open is formed, and this space portion functions as the second container 107 . Furthermore, one open end of the space functioning as the second container 107 functions as the second sample supply port 108 , and the other open end functions as the second suction port 109 .

另外,在第2容器107内的第2部件102上设有保持用于光学测定的试剂的试剂保持部110。而且,在从第1试样供给口105至电极201a、202a的距离Y长于从第2试样供给口108至试剂保持部110的距离X的位置(即满足关系式X<Y的位置)上,配置有试剂保持部110。In addition, a reagent holder 110 for holding a reagent for optical measurement is provided on the second member 102 in the second container 107 . Furthermore, at a position where the distance Y from the first sample supply port 105 to the electrodes 201a and 202a is longer than the distance X from the second sample supply port 108 to the reagent holding part 110 (that is, a position that satisfies the relational expression X<Y) , a reagent holding unit 110 is arranged.

如图3所示,本实施方式的测定仪器100的试剂保持部110设置在第2部件102上的与第3部件103相对的面102a上。As shown in FIG. 3 , the reagent holding portion 110 of the measuring instrument 100 according to this embodiment is provided on a surface 102 a of the second member 102 facing the third member 103 .

第2部件102的外表面由3个面102b、102c和102d构成,处于挟持在里侧形成有试剂保持部110的第1面102b的位置上的2个面102c、102d中的一个作为光入射部111发挥功能,另一个作为光出射部112发挥功能。光入射部111和光出射部112相当于本发明的光学测定部。The outer surface of the second member 102 is composed of three surfaces 102b, 102c, and 102d, and one of the two surfaces 102c, 102d at a position sandwiching the first surface 102b on which the reagent holding portion 110 is formed on the back side is incident as light. One part 111 functions, and the other functions as the light emitting part 112 . The light incident part 111 and the light emitting part 112 correspond to the optical measurement part of this invention.

这里,当使用本实施方式的测定仪器110时,如后所述,将测定仪器100的一部分浸渍于例如采集到容器内的尿中后,通过测定装置从第1抽吸口106和第2抽吸口109抽吸尿,供给至第1容器104和第2容器107内。Here, when using the measuring instrument 110 of this embodiment, as described later, after immersing a part of the measuring instrument 100 in, for example, urine collected in a container, the first suction port 106 and the second suction port 106 and the second suction port are drawn through the measuring device. The suction port 109 sucks urine and supplies it into the first container 104 and the second container 107 .

因此,在第1试样供给口105和第2试样供给口108附近设置有成为用于测定仪器100浸渍于上述试样中的基准的基准线115。如果有这种基准线115,则可以在将测定仪器100浸渍于作为试样的尿中的工序中,将测定仪器100浸渍在上述试样中至该基准线115的部分,可以确实地将尿供给至第1容器104和第2容器107内,同时可以确实地进行测定。Therefore, near the first sample supply port 105 and the second sample supply port 108, a reference line 115 serving as a reference for immersing the measuring instrument 100 in the sample is provided. If there is such a reference line 115, in the process of immersing the measuring device 100 in urine as a sample, the measuring device 100 can be immersed in the sample up to the part of the reference line 115, and the urine can be reliably measured. While being supplied into the first container 104 and the second container 107, measurement can be reliably performed.

基准线115的粗细和形状只要是可以目视的程度即可,没有特别限定。图1中,仅设置于测定仪器100的1个侧面上,但也可以在所有侧面上设置基准线。The thickness and shape of the reference line 115 are not particularly limited as long as they are visible. In FIG. 1 , the reference line is provided on only one side of the measuring instrument 100 , but the reference line may be provided on all sides.

这种基准线115例如可以通过印刷在测定仪器100的表面上而形成,也可以通过设置凹槽或棱纹而形成。Such a reference line 115 may be formed, for example, by printing on the surface of the measuring instrument 100, or by providing grooves or ribs.

接着,使用图3说明本实施方式的测定仪器100的制作方法。图3为本实施方式的测定仪器的分解立体图。Next, a method of manufacturing the measurement device 100 of this embodiment will be described with reference to FIG. 3 . Fig. 3 is an exploded perspective view of the measuring instrument of the present embodiment.

第1部件101、第2部件102和第3部件103分别为透明聚苯乙烯制,可以通过使用模具的成型而获得。成型中可以使用公知的树脂成型技术。The first member 101, the second member 102, and the third member 103 are each made of transparent polystyrene and can be obtained by molding using a mold. For molding, known resin molding techniques can be used.

第1部件101和第2部件102分别具有凹部,通过挟持板状的第3部件103而相互地组合,从而一体地构成第1容器104和第2容器107。The 1st member 101 and the 2nd member 102 each have a recessed part, and are mutually combined by pinching the plate-shaped 3rd member 103, and the 1st container 104 and the 2nd container 107 are integrally comprised.

第1部件101、第2部件102和第3部件103的尺寸例如均可以为宽度(图3的A)为10mm、长度(图3的B)为84mm、厚度为1mm。The dimensions of the first member 101, the second member 102, and the third member 103 may be, for example, a width (A of FIG. 3 ) of 10 mm, a length (B of FIG. 3 ) of 84 mm, and a thickness of 1 mm.

另外,第1部件101和第2部件102的高度(图3的C)例如均可以为6mm。In addition, the heights (C of FIG. 3 ) of the first member 101 and the second member 102 may both be 6 mm, for example.

接着,在第2部件102的凹部底面、即面102上形成试剂保持部110。Next, the reagent holding portion 110 is formed on the bottom surface of the concave portion of the second member 102 , that is, the surface 102 .

例如,使用微量注射器等将对用于光学测定的试剂即人白蛋白的抗体的水溶液以恒定量滴加到第2部件102的凹部底面(面102a),由此进行涂覆,然后将其静置在室温~30℃左右的环境下使水分蒸发,从而可以以干燥状态附载试剂。例如,可以使用浓度为8mg/dL的上述抗体的水溶液,以0.7mL的滴加量滴加至面积为5cm2的部分上。For example, an aqueous solution of an antibody to human albumin, which is a reagent used for optical measurement, is dripped at a constant amount onto the bottom surface (surface 102a) of the concave portion of the second member 102 using a microsyringe or the like, and then it is statically coated. The reagent can be loaded in a dry state by placing it in an environment from room temperature to about 30°C to evaporate water. For example, an aqueous solution of the above-mentioned antibody having a concentration of 8 mg/dL can be used to drop 0.7 mL onto a portion having an area of 5 cm 2 .

含有涂覆的试剂的水溶液的浓度和量可以根据所需要的仪器的特性和第2部件102的形成位置的空间限制而适当地选择。另外,第2部件102的试剂保持部110的位置或面积可以考虑试剂对试样的溶解性或光学测定部的位置等来适当地选择。The concentration and amount of the aqueous solution containing the applied reagent can be appropriately selected according to the required characteristics of the device and the space constraints of the formation position of the second member 102 . In addition, the position and area of the reagent holding portion 110 of the second member 102 can be appropriately selected in consideration of the solubility of the reagent in the sample, the position of the optical measurement portion, and the like.

另外,对人白蛋白的抗体可以通过以往公知的方法获得。例如通过蛋白A柱色谱法将免疫了人白蛋白的兔的抗血清精制后,使用透析管进行透析,从而获得抗人白蛋白抗体。In addition, antibodies against human albumin can be obtained by conventionally known methods. For example, anti-human albumin antibodies can be obtained by purifying the antiserum of rabbits immunized with human albumin by protein A column chromatography and dialysis using a dialysis tube.

另一方面,在位于第3部件103的第1部件101侧的面103a上配置一对导电部。例如,可以将具有与一对导电部相同形状的空隙的丙烯酸树脂性掩模配置在第3部件103上,介由其溅射金后除去掩模,从而形成一对导电部。代替溅射,还可以用蒸镀按照相同的顺序形成。On the other hand, a pair of conductive parts are arranged on the surface 103 a of the third member 103 on the side of the first member 101 . For example, an acrylic resin mask having voids of the same shape as the pair of conductive parts can be placed on the third member 103, gold can be sputtered through it, and the mask can be removed to form a pair of conductive parts. Instead of sputtering, vapor deposition can also be formed in the same order.

一对导电部的尺寸没有特别限定,例如可以分别是宽度为2mm左右、长度为14mm左右、厚度为5μm左右。为了规定电极201a、202a和连接部201b、202b的大小(长度),按照导电部的两端露出并覆盖导电部的一部分的方式粘贴由绝缘性树脂构成的盖子203。作为盖子203,例如可以使用宽度为10mm左右、长度为5mm左右、厚度为0.1mm左右的涂覆有丙烯酸系粘接剂的PET制薄膜。按照电极201a、202a的长度例如分别为4mm、连接部的长度例如分别为5mm的方式配置盖子203。The size of the pair of conductive parts is not particularly limited, for example, the width may be about 2 mm, the length may be about 14 mm, and the thickness may be about 5 μm. In order to define the size (length) of the electrodes 201a, 202a and the connection parts 201b, 202b, a cover 203 made of insulating resin is attached so that both ends of the conductive part are exposed and part of the conductive part is covered. As the cover 203, for example, a PET film coated with an acrylic adhesive having a width of about 10 mm, a length of about 5 mm, and a thickness of about 0.1 mm can be used. The cover 203 is arranged so that the lengths of the electrodes 201a and 202a are, for example, 4 mm, respectively, and the lengths of the connecting parts are, for example, 5 mm.

导电部、电极、连接部的材料、面积、厚度、形状和位置等可以考虑所需要的仪器的特性、光学测定系的位置等来适当调整。The material, area, thickness, shape, and position of the conductive portion, electrode, and connection portion can be appropriately adjusted in consideration of the required characteristics of the instrument, the position of the optical measurement system, and the like.

另外,使用公知的方法将作为酶的葡糖氧化酶和作为电子传递体的锇络合物固定并附载于电极201a、202a的表面上。In addition, glucose oxidase as an enzyme and osmium complex as an electron transporter were immobilized and supported on the surfaces of the electrodes 201a and 202a using known methods.

例如,将配位键合有二联吡啶氯化锇的聚乙烯基咪唑的溶液与葡糖氧化酶的溶液混合后涂覆在电极201a、202a上,在电极201a、202a上的上述溶液中添加作为胺交联剂的聚乙二醇二缩水甘油醚并混合。静置1小时左右后,使用蒸馏水洗涤电极201a、202a的表面。For example, a solution of polyvinylimidazole coordinatingly bonded with bipyridyl osmium chloride and a solution of glucose oxidase are mixed and coated on the electrodes 201a and 202a, and then added to the above solutions on the electrodes 201a and 202a Polyethylene glycol diglycidyl ether as an amine crosslinker and mixed. After standing still for about 1 hour, the surfaces of the electrodes 201a and 202a were washed with distilled water.

将如上获得的第1部件101、第2部件102和第3部件103以图3虚线所示的位置关系进行接合,组装测定仪器100。在第1部件101和第3部件103的接合部分以及第2部件102和第3部件103的接合部分上涂覆例如环氧树脂等粘接剂后,粘合各部件并静置,使其干燥,从而组装测定仪器100。The first member 101 , the second member 102 , and the third member 103 obtained above are joined in the positional relationship shown by the dotted line in FIG. 3 , and the measuring instrument 100 is assembled. After applying an adhesive such as epoxy resin to the joining portion of the first member 101 and the third member 103 and the joining portion of the second member 102 and the third member 103, each member is bonded and left to dry. , so that the measuring instrument 100 is assembled.

另外,也可以不使用粘接剂,在粘贴第1部件101、第2部件102和第3部件103后,使用市售的焊接机通过热或超声波将接合部分焊接。如上所述,可以获得图1和图2所示的测定仪器100。In addition, after bonding the first member 101, the second member 102, and the third member 103 without using an adhesive, the bonded portions may be welded by heat or ultrasonic waves using a commercially available welding machine. As described above, the measuring instrument 100 shown in FIGS. 1 and 2 can be obtained.

2.测定装置2. Measuring device

接着,使用附图说明本发明的测定装置的实施方式。使用图4和图5说明本实施方式的测定装置的构成。图4为表示本实施方式的测定装置的立体图,图5为表示本实施方式的测定装置的构成的模块图。Next, embodiments of the measuring device of the present invention will be described using the drawings. The configuration of the measuring device according to this embodiment will be described with reference to FIGS. 4 and 5 . FIG. 4 is a perspective view showing the measurement device of the present embodiment, and FIG. 5 is a block diagram showing the configuration of the measurement device of the present embodiment.

如图4所示,本实施方式的测定装置300具有用于安装测定仪器100的测定仪器安装部301,在测定仪器安装部301上具有用于可装卸地接合于测定仪器100的第1抽吸口106和第2抽吸口109的仪器安装口(未图示)以及用于与连接部201b、202b电连接的端子(未图示)。另外,还设有作为显示测定结果的显示器的显示部302、试样抽吸开始按钮303、以及测定仪器取出按钮304。As shown in FIG. 4 , the measuring device 300 of the present embodiment has a measuring instrument mounting portion 301 for mounting the measuring instrument 100, and the measuring instrument mounting portion 301 has a first suction pump for detachably connecting to the measuring instrument 100. The port 106 and the instrument mounting port (not shown) of the second suction port 109 and terminals (not shown) for electrically connecting to the connection parts 201b, 202b. In addition, a display unit 302 serving as a display for displaying measurement results, a sample suction start button 303 , and a measuring instrument take-out button 304 are also provided.

在仪器安装口的内侧设有2个凸部,在安装测定仪器100时,凸部分别插入到第1抽吸口106和第2抽吸口109中。此时,优选将例如特氟隆(注册商标)等氟树脂或异戊二烯橡胶等具有弹性的树脂制环状密封材料等设置在上述凸部的周围,以使得不发生接合部的空气泄漏,从而提高凸部与第1抽吸口106和第2抽吸口109的密合性。上述密封材料可以为线状,另外,上述凸部本身还可以由特氟隆(注册商标)或异戊二烯橡胶等具有弹性的树脂构成。Two protrusions are provided inside the instrument mounting port, and the protrusions are respectively inserted into the first suction port 106 and the second suction port 109 when the measuring instrument 100 is mounted. At this time, it is preferable to provide, for example, a fluororesin such as Teflon (registered trademark) or an elastic resin annular sealing material such as isoprene rubber around the above-mentioned protrusion so that air leakage does not occur at the junction. , thereby improving the adhesion between the convex portion and the first suction port 106 and the second suction port 109 . The sealing material may be linear, and the protrusion itself may be made of elastic resin such as Teflon (registered trademark) or isoprene rubber.

如图5所示,在测定装置300的内部设有用于发出入射到安装于测定仪器安装部301的测定仪器100的光学测定部的入射光的光源407、用于接受从光学测定部射出的出射光的受光器408、用于对测定仪器100的电极201a、202a施加电压的电压施加部402、和用于对来自电极201a、202a的电信号进行测定的电信号测定部405。As shown in FIG. 5 , a light source 407 for emitting incident light to the optical measuring section of the measuring instrument 100 attached to the measuring instrument mounting section 301 is provided inside the measuring device 300 , and for receiving light emitted from the optical measuring section. A photoreceiver 408 for emitting light, a voltage application unit 402 for applying a voltage to the electrodes 201a, 202a of the measuring instrument 100, and an electrical signal measurement unit 405 for measuring electrical signals from the electrodes 201a, 202a.

另外,在测定装置300的内部还设有作为用于基于通过受光器408接受的出射光和通过电信号测定部405测定的电信号中的至少一个来对试样中所含的待测物质进行检测或定量的运算部的CPU401、作为用于将试样抽吸至测定仪器100的第1容器104和第2容器107内的抽吸部的活塞机构404。In addition, inside the measurement device 300, there is also a device for measuring the substance to be measured contained in the sample based on at least one of the emitted light received by the light receiver 408 and the electrical signal measured by the electrical signal measurement unit 405. The CPU 401 of the calculation unit for detection or quantification, and the piston mechanism 404 as a suction unit for sucking a sample into the first container 104 and the second container 107 of the measuring instrument 100 .

作为本实施方式的光源407,例如可以使用发出650nm波长的光的半导体激光。还可以使用发光二极管(LED)等来代替它。As the light source 407 of this embodiment, for example, a semiconductor laser emitting light with a wavelength of 650 nm can be used. A light emitting diode (LED) or the like may also be used instead of it.

另外,本实施方式是假设使用利用免疫比浊法的测定而选择650nm的照射和受光波长,但是该波长可以根据测定法或测定对象来适当选择。In addition, in this embodiment, it is assumed that the measurement by immunoturbidimetry is used and the irradiation and light reception wavelengths of 650 nm are selected, but this wavelength can be appropriately selected according to the measurement method or measurement object.

作为本实施方式的受光器408,例如可以使用光电二极管。还可以使用光电万用表(photomultimeter)、电荷耦合型元件(CCD)等作为受光器408来代替它。As the photoreceiver 408 in this embodiment, for example, a photodiode can be used. It is also possible to use a photomultimeter, a charge-coupled device (CCD), or the like as the photoreceiver 408 instead of it.

另外,本实施方式的活塞机构404的构成是利用线性步进电动机使活塞工作。In addition, the piston mechanism 404 of this embodiment is configured so that the piston is operated by a linear stepping motor.

进而,在测定装置300的内部设有作为记忆部的存储器409,其中存储有与表示第1待测物质的人白蛋白的浓度与由受光器408接受的出射光强度的关系的第1校准曲线相关的数据、及与表示第2待测物质的葡萄糖的浓度与通过电信号测定部405测定的电信号的关系的第2校准曲线相关的数据。Furthermore, a memory 409 serving as a storage unit is provided inside the measurement device 300, and a first calibration curve representing the relationship between the concentration of human albumin, the first analyte substance, and the intensity of emitted light received by the light receiver 408 is stored therein. The related data and the data related to the second calibration curve showing the relationship between the glucose concentration of the second analyte substance and the electrical signal measured by the electrical signal measuring unit 405 .

3.测定方法3. Measurement method

接着,参照图4和图5说明使用本实施方式的测定仪器100和测定装置300来测定试样中的待测物质的方法。以下对使用尿作为试样的例子进行说明。Next, a method of measuring a test substance in a sample using the measuring instrument 100 and the measuring device 300 of this embodiment will be described with reference to FIGS. 4 and 5 . An example using urine as a sample will be described below.

首先,将测定仪器100的第1抽吸口106和第2抽吸口109接合于测定仪器安装部301内的仪器安装口(未图示),从而在测定仪器安装部301上安装测定仪器100。由此,按照与测定仪器100的2个电极201a、202a电导通的方式将连接部201b、202b与设置在测定仪器安装部301内部的2个端子分别相接触。First, the first suction port 106 and the second suction port 109 of the measuring instrument 100 are joined to the instrument mounting port (not shown) in the measuring instrument mounting part 301, thereby mounting the measuring instrument 100 on the measuring instrument mounting part 301. . Thereby, the connection parts 201b, 202b are brought into contact with the two terminals provided inside the measuring instrument mounting part 301 so as to be electrically connected to the two electrodes 201a, 202a of the measuring instrument 100 .

此时,设置在测定装置300内的由微开关构成的测定仪器插入感知开关(未图示)工作,作为控制部发挥功能的CPU401感知到测定仪器100的插入,通过电压施加部402在测定仪器100的2个电极201a、202a之间施加电压(例如电极201a相比于电极202a为+0.2V的电压)。At this time, a measuring instrument insertion sensing switch (not shown) constituted by a microswitch provided in the measuring device 300 operates, and the CPU 401 functioning as a control unit senses the insertion of the measuring instrument 100, and the measuring instrument 100 is inserted through the voltage applying unit 402. A voltage is applied between the two electrodes 201a and 202a of 100 (for example, the electrode 201a has a voltage of +0.2V compared to the electrode 202a).

接着,将测定仪器100浸渍于例如采集在设置于便器内的接尿容器或纸杯等可搬运容器内的尿中,至少达到基准线115的位置,然后将测定仪器100的第1试样供给口105和第2试样供给口108浸渍于尿中。Next, the measuring instrument 100 is immersed in urine collected in a portable container such as a urine container or a paper cup installed in the toilet until it reaches at least the position of the reference line 115, and then the first sample supply port of the measuring instrument 100 is inserted. 105 and the second sample supply port 108 are immersed in urine.

这里,使用者确认至少第1试样供给口105和第2试样供给口108浸渍于尿中,在此状态下按下试样抽吸开始按钮303,使设于测定装置300内的抽吸手段的一部分即活塞机构404工作,由此,活塞机构404内的活塞移动,分别将规定量(例如3mL)的尿从测定仪器100的第1试样供给口105和第2试样供给口108抽吸至第1容器104和第2容器107内,以使得试样的液面到达盖子203的位置。Here, the user confirms that at least the first sample supply port 105 and the second sample supply port 108 are immersed in urine, presses the sample suction start button 303 in this state, and the suction pump provided in the measurement device 300 is activated. Piston mechanism 404, which is a part of the means, operates, whereby the piston in piston mechanism 404 moves, and a predetermined amount (for example, 3 mL) of urine is respectively supplied from first sample supply port 105 and second sample supply port 108 of measuring instrument 100. It is sucked into the first container 104 and the second container 107 so that the liquid surface of the sample reaches the position of the lid 203 .

此时,通过将活塞保持在抽吸试样时的位置,尿被保持在第1容器104和第2容器107内,不会从第1试样供给口105或第2试样供给口108中漏出、也不会被抽吸至活塞机构404内部。At this time, by keeping the piston at the position when the sample is sucked, the urine is held in the first container 104 and the second container 107, and urine does not flow from the first sample supply port 105 or the second sample supply port 108. It will not leak out or be sucked into the piston mechanism 404.

当供给至第1容器104内的尿与电极201a、202a接触时,由于电流在两电极间流动,因此电信号测定部405感知由此所引起的电信号的变化。When the urine supplied into the first container 104 comes into contact with the electrodes 201a and 202a, an electric current flows between the two electrodes, and the electrical signal measuring unit 405 detects a change in the electrical signal caused by this.

伴随着该感知,CPU401开始利用作为计时部406的计时器进行计时。另外,伴随着上述感知,CPU401阻断电压施加部402所施加的电压。当开始利用计时器进行计时时,显示部302显示计时开始。该显示后,可以将第1试样供给口105和第2试样供给口108从尿中提起。Accompanied by this perception, the CPU 401 starts counting time by the timer as the timer unit 406 . In addition, the CPU 401 blocks the voltage applied by the voltage applying unit 402 following the above-mentioned sensing. When the timer starts counting, the display unit 302 displays that the counting is started. After this display, the first sample supply port 105 and the second sample supply port 108 can be lifted out of the urine.

供给至第2容器107内的尿将附载于试剂保持部110的干燥状态的试剂即抗人白蛋白抗体溶解,发生尿中抗原即人白蛋白与抗人白蛋白抗体的免疫反应。The urine supplied into the second container 107 dissolves the anti-human albumin antibody, which is the dry reagent carried on the reagent holding unit 110, and an immune reaction between the human albumin, which is an antigen in urine, and the anti-human albumin antibody occurs.

接着,根据来自计时部406的信号,CPU401判断尿到达电极201a、202a后经过规定时间(例如2分钟),则CPU401实施利用光源407的光照射和利用电压施加部402的电压施加(例如电极201a相比于电极202a为+0.5V的电压)。Then, according to the signal from the timer unit 406, the CPU 401 judges that a predetermined time (for example, 2 minutes) has elapsed since the urine reached the electrodes 201a and 202a, and then the CPU 401 implements light irradiation by the light source 407 and voltage application by the voltage application unit 402 (for example, the electrode 201a A voltage of +0.5 V compared to electrode 202a).

通过设置于测定装置300内的受光器408在规定时间内(例如3分钟)接受从光源407发出、通过测定仪器100的光入射部111入射到第2容器107内、在尿中透射和散射、并从光出射部112射出的光。The photoreceiver 408 installed in the measurement device 300 receives the light emitted from the light source 407 within a predetermined time (for example, 3 minutes), enters the second container 107 through the light incident part 111 of the measurement instrument 100, transmits and scatteres in urine, And the light emitted from the light emitting part 112 .

CPU401读取存储于存储器409中的与表示出射光强度和人白蛋白浓度的关系的第1校准曲线相关的数据,通过参照该第1校准曲线,CPU401将由受光器408接受的出射光强度换算为人白蛋白浓度。The CPU 401 reads data related to the first calibration curve representing the relationship between the intensity of the emitted light and the concentration of human albumin stored in the memory 409, and by referring to the first calibration curve, the CPU 401 converts the intensity of the emitted light received by the light receiver 408 into human albumin concentration.

所得人白蛋白浓度显示于显示部302中。通过在显示部302中显示人白蛋白,使用者可知人白蛋白浓度测定完成。The obtained concentration of human albumin is displayed on the display unit 302 . By displaying human albumin on the display unit 302, the user can know that the measurement of the concentration of human albumin is completed.

另一方面,通过来自计时部406的信号,当CPU401判断施加上述电压后经过规定时间(例如1分钟)时,通过电信号测定部405测定在电极201a和电极202a之间流动的电流等电信号。CPU401读取存储于存储器409中的与表示电信号和葡萄糖(尿糖)浓度关系的第2校准曲线相关的数据,通过参照该数据,CPU401将测定的电信号换算为尿中的葡萄糖浓度。On the other hand, when the CPU 401 judges that a predetermined time (for example, 1 minute) has elapsed after the application of the voltage by the signal from the timer unit 406, the electrical signal measuring unit 405 measures an electrical signal such as a current flowing between the electrode 201a and the electrode 202a. . The CPU 401 reads data related to the second calibration curve representing the relationship between the electrical signal and glucose (urine sugar) concentration stored in the memory 409, and by referring to the data, the CPU 401 converts the measured electrical signal into the urine glucose concentration.

所得葡萄糖浓度显示于显示部302中。通过在显示部302中显示葡萄糖浓度,使用者可知葡萄糖浓度测定完成。优选将所得葡萄糖浓度和人白蛋白浓度与计时部406所计时的时刻一起保存于存储器409中。The obtained glucose concentration is displayed on the display unit 302 . By displaying the glucose concentration on the display unit 302, the user can know that the glucose concentration measurement has been completed. The obtained glucose concentration and human albumin concentration are preferably stored in the memory 409 together with the time counted by the timer unit 406 .

最后,使用者按下测定仪器取出按钮304,从而测定仪器取出机构410工作,移动活塞机构404内的活塞,从而将第1容器104和第2容器107内的尿从第1试样供给口105和第2试样供给口108排出到便器内或纸杯等容器内,然后将测定仪器100从测定装置300自动地取出。Finally, the user presses the measuring instrument take-out button 304, so that the measuring instrument taking-out mechanism 410 works, and the piston in the piston mechanism 404 is moved to discharge the urine in the first container 104 and the second container 107 from the first sample supply port 105. and the second sample supply port 108 into a container such as a toilet or a paper cup, and then the measuring instrument 100 is automatically taken out from the measuring device 300 .

另外,还可以不在测定装置上设置这种仪器取出和试样排出的机构,使用者手动地将测定仪器100从测定仪器安装部301中取出。In addition, the measuring device may not be provided with such a mechanism for taking out the instrument and discharging the sample, and the user may manually take out the measuring instrument 100 from the measuring instrument mounting part 301 .

所得尿糖浓度和人白蛋白浓度可以通过记录部411记录于SD卡等记忆介质中。通过保存在可以取出的记忆介质中,可以将测定结果容易地从测定装置300取出,因此可以将上述记忆介质送到或邮寄到分析专家处拜托分析。The obtained urine sugar concentration and human albumin concentration can be recorded in a storage medium such as an SD card through the recording unit 411 . Since the measurement results can be easily taken out from the measurement device 300 by being stored in a removable memory medium, the above-mentioned memory medium can be sent or mailed to an analyst for analysis.

另外,所得尿糖浓度和人白蛋白浓度可以通过发送部412发送至测定装置300外。由此,由于可以将测定结果发送至医院内的分析相关部门或分析相关人士等,由上述分析相关部门或分析相关人士等对其进行分析,因而可以缩短从测定至分析的时间。In addition, the obtained urine sugar concentration and human albumin concentration can be transmitted to the outside of the measurement device 300 through the transmission unit 412 . Thereby, since the measurement result can be sent to the analysis-related department or analysis-related person in the hospital, and analyzed by the above-mentioned analysis-related department or analysis-related person, etc., the time from measurement to analysis can be shortened.

另外,具备用于接收上述分析相关部门或分析相关人士等分析的结果的接收部413。由此,可以将分析结果迅速地反馈至使用者。In addition, a receiving unit 413 for receiving the results of the analysis by the above-mentioned analysis-related departments, analysis-related persons, etc. is provided. Thereby, the analysis result can be promptly fed back to the user.

如上所述,通过将试样1次供给至第1容器104和第2容器107内,使用1个测定仪器100即可进行试样的光学测定和电化学测定。As described above, by supplying the sample once into the first container 104 and the second container 107 , the optical measurement and the electrochemical measurement of the sample can be performed using one measuring instrument 100 .

另外,通过在测定仪器100的第1容器104内设置电极201a、202a,在第2容器107内设置试剂保持部110,光学测定所需要的试剂不会扩散至电化学测定部,不会影响电化学测定,因而可以对多个测定项目迅速且正确地进行测定。In addition, by providing the electrodes 201a and 202a in the first container 104 of the measuring instrument 100, and providing the reagent holding part 110 in the second container 107, the reagents required for optical measurement will not diffuse into the electrochemical measurement part, and will not affect the electrochemical measurement part. For chemical measurement, it is possible to quickly and accurately measure multiple measurement items.

另外,将试剂保持部110配置在从第1试样供给口105与电极201a、202a的距离长于从第2试样供给口108与试剂保持部110的距离的位置上,通过检测来自电极的电信号的变化来感知试样到达电极,根据该检测将入射光自动地照射于试样,因而可以防止试样不足所导致的在试剂溶解于试样之前错误地进行光学测定。In addition, the reagent holding part 110 is arranged at a position where the distance from the first sample supply port 105 to the electrodes 201a and 202a is longer than the distance from the second sample supply port 108 to the reagent holding part 110. The arrival of the sample at the electrode is sensed by a change in the signal, and incident light is automatically irradiated on the sample based on the detection, thereby preventing erroneous optical measurement before the reagent dissolves in the sample due to insufficient sample.

以上说明了本发明的实施方式的一个例子,但测定仪器100的形状只要满足本发明的构成要件且可以获得本发明的效果即可,并非局限于上述实施方式。An example of the embodiment of the present invention has been described above, but the shape of the measurement device 100 is not limited to the above-mentioned embodiment as long as it satisfies the constituent requirements of the present invention and can obtain the effects of the present invention.

这里,图6为表示上述实施方式的测定仪器的变形例的立体图、图7为图6的B-B部分的剖面图。分别与图1和图2同样的构成要素带有相同符号,并省略说明。Here, FIG. 6 is a perspective view showing a modified example of the measuring instrument of the above-mentioned embodiment, and FIG. 7 is a cross-sectional view of part B-B of FIG. 6 . Components that are the same as those in FIG. 1 and FIG. 2 are assigned the same symbols, and description thereof will be omitted.

如图6所示,本变形例的测定仪器100具有内部含有作为第1容器104和第2容器107发挥功能的空间的长方体形状。另外,本变形例的测定仪器100具备第1部件101和第2部件102,在第1部件101和第2部件102的侧面分别设有第1试样供给口105和第2试样供给口108。As shown in FIG. 6 , the measuring instrument 100 of this modified example has a rectangular parallelepiped shape including spaces that function as the first container 104 and the second container 107 inside. In addition, the measuring instrument 100 of this modified example includes a first member 101 and a second member 102, and a first sample supply port 105 and a second sample supply port 108 are respectively provided on the side surfaces of the first member 101 and the second member 102. .

[实施方式2][Embodiment 2]

1.测定仪器1. Measuring instrument

以下说明本发明的测定仪器的实施方式2。在本实施方式中,与实施方式1同样,对试样为尿、第1待测物质为人白蛋白、第2待测物质为葡萄糖的情况进行说明。Embodiment 2 of the measurement device of the present invention will be described below. In this embodiment, as in Embodiment 1, a case where the sample is urine, the first analyte is human albumin, and the second analyte is glucose will be described.

首先,使用图8~10说明本实施方式的测定仪器的结构。图8为本实施方式的测定仪器的立体图,图9为图8的C-C剖面图。图10为图8和图9所示的测定仪器600的分解立体图。另外,对于与图1~3所示的构成要素通用的构成要素使用相同符号,并省略说明。First, the configuration of the measuring instrument of this embodiment will be described using FIGS. 8 to 10 . FIG. 8 is a perspective view of the measuring instrument according to this embodiment, and FIG. 9 is a cross-sectional view taken along line C-C of FIG. 8 . FIG. 10 is an exploded perspective view of the measuring instrument 600 shown in FIGS. 8 and 9 . In addition, the same code|symbol is used for the component common to the component shown in FIGS. 1-3, and description is abbreviate|omitted.

本实施方式的测定仪器600具备透明聚苯乙烯制的盖部件601、隔板602、第2部件102和第3部件103。The measuring instrument 600 of the present embodiment includes a cover member 601 made of transparent polystyrene, a spacer 602 , a second member 102 , and a third member 103 .

通过组合设有空气孔603的盖部件601、设有狭缝604的隔板602和第3部件103,形成第1试样供给口105开放的空间。该空间作为第1容器104发挥功能。A space in which the first sample supply port 105 is opened is formed by combining the cover member 601 provided with the air hole 603 , the partition plate 602 provided with the slit 604 , and the third member 103 . This space functions as the first container 104 .

在第3部件103上设置有一对导电部201、202。在一对导电部201、202中,露出至第1容器104内的部分作为一对电极201a、202a发挥功能,露出至测定仪器600外侧的部分作为一对连接部201b、202b发挥功能。第1容器104为空腔结构,当试样与第1试样供给口105相接触时,则第1容器104内的空气从空气孔603排出,通过毛细管现象将试样从第1试样供给口105供给至第1容器104内。A pair of conductive parts 201 and 202 are provided on the third member 103 . Of the pair of conductive parts 201, 202, the part exposed inside the first container 104 functions as a pair of electrodes 201a, 202a, and the part exposed outside the measuring instrument 600 functions as a pair of connecting parts 201b, 202b. The first container 104 has a cavity structure, and when the sample is in contact with the first sample supply port 105, the air in the first container 104 is discharged from the air hole 603, and the sample is supplied from the first sample by capillary phenomenon. The port 105 supplies into the first container 104 .

盖部件601和隔板602的尺寸例如可以均是宽度(图10的D)为3mm、长度为84mm、厚度为300μm,狭缝604的宽度例如可以为1mm。The dimensions of the cover member 601 and the spacer 602 can be, for example, 3 mm in width (D in FIG. 10 ), 84 mm in length, and 300 μm in thickness, and the width of the slit 604 can be 1 mm, for example.

与实施方式1同样,通过组合第2部件102和第3部件103,形成两端开放的空间,该空间部分作为第2容器107发挥功能。作为第2容器107发挥功能的空间的一个开放端作为第2试样供给口108发挥功能,另一个开放端作为第2抽吸口109发挥功能。Similar to Embodiment 1, by combining the second member 102 and the third member 103 , a space with both ends open is formed, and this space portion functions as the second container 107 . One open end of the space functioning as the second container 107 functions as the second sample supply port 108 , and the other open end functions as the second suction port 109 .

另外,在第2容器107内的第2部件102上设有保持用于光学测定的试剂的试剂保持部110。将试剂保持部110配置在从第1试样供给口105与电极201a、202a的距离Y长于从第2试样供给口108与试剂保持部110的距离X的位置上。第2部件102和第3部件103的尺寸可以与实施方式相同。In addition, a reagent holder 110 for holding a reagent for optical measurement is provided on the second member 102 in the second container 107 . The reagent holding part 110 is arranged at a position where the distance Y from the first sample supply port 105 to the electrodes 201 a and 202 a is longer than the distance X from the second sample supply port 108 to the reagent holding part 110 . The dimensions of the second member 102 and the third member 103 may be the same as those in the embodiment.

本实施方式的测定仪器600中,试剂保持部110设置在第2部件102上的与第3部件103相对的面102a上。构成第2部件102外表面的3个面中,处于挟持在里侧形成有试剂保持部110的第1面102b的位置上的2个面102c、102d中的一个作为光入射部111发挥功能,另一个作为光出射部112发挥功能。光入射部111和光出射部112相当于本发明的光学测定部。In the measurement device 600 of the present embodiment, the reagent holding portion 110 is provided on the surface 102 a of the second member 102 facing the third member 103 . Among the three surfaces constituting the outer surface of the second member 102, one of the two surfaces 102c and 102d at the position sandwiching the first surface 102b on which the reagent holding portion 110 is formed on the back side functions as the light incident portion 111, The other one functions as the light emitting unit 112 . The light incident part 111 and the light emitting part 112 correspond to the optical measurement part of this invention.

接着,使用图10说明本实施方式的测定仪器600的制作方法。图10为本实施方式的测定仪器的分解立体图。Next, a method of manufacturing the measurement device 600 of this embodiment will be described using FIG. 10 . Fig. 10 is an exploded perspective view of the measuring instrument of this embodiment.

与实施方式1同样,盖部件601、隔板602、第2部件102和第3部件103为透明的聚苯乙烯制,可以通过使用模具的成型来获得。Like Embodiment 1, the cover member 601, the spacer 602, the second member 102, and the third member 103 are made of transparent polystyrene and can be obtained by molding using a mold.

接着,在第2部件102的凹部底面102a上形成试剂保持部110。试剂保持部110的形成方法与实施方式1相同,因此省略。Next, the reagent holding portion 110 is formed on the bottom surface 102 a of the concave portion of the second member 102 . The method of forming the reagent holding portion 110 is the same as that in Embodiment 1, so it is omitted.

另一方面,在第3部件103上形成一对导电部201、202。导电部201、202配置在下述位置上:当将第3部件103与盖部件601和隔板602组合时,导电部的一部分露出到由设在隔板602的狭缝604所形成的第1容器104内。这里,分别使导电部201、202为L字状和倒L字状。On the other hand, a pair of conductive parts 201 and 202 are formed on the third member 103 . The conductive parts 201 and 202 are arranged at positions where, when the third member 103 is combined with the lid member 601 and the partition 602, a part of the conductive part is exposed to the first container formed by the slit 604 provided in the partition 602. 104 inside. Here, the conductive parts 201 and 202 are respectively made into an L-shape and an inverted L-shape.

导电部201、202的形成方法除了不粘贴由绝缘性树脂构成的盖子之外,与实施方式1相同,因此省略说明。The method of forming the conductive parts 201 and 202 is the same as that of Embodiment 1 except that the cover made of insulating resin is not pasted, and thus the description thereof will be omitted.

接着,优选对第3部件103、盖部件601和由狭缝604所构成的第1容器104的内表面实施亲水性处理。Next, it is preferable to perform a hydrophilic treatment on the inner surfaces of the third member 103 , the cover member 601 , and the first container 104 constituted by the slit 604 .

例如,将0.05mL的0.1%卵磷脂/甲苯溶液滴加在构成第1容器104内表面的第3部件103、盖部件601和狭缝604的部分(面)的整个表面上,进行涂覆。在大气中静置2~3分钟,使甲苯溶剂蒸发,从而可以使上述整个表面带有亲水性。For example, 0.05 mL of a 0.1% lecithin/toluene solution is dropped onto the entire surface of the third member 103 , the cover member 601 , and the slit 604 constituting the inner surface of the first container 104 for coating. By standing still in the air for 2 to 3 minutes to evaporate the toluene solvent, the entire surface can be made hydrophilic.

另外,可以使用乙二醇烷基醚(TritonX-100)等表面活性剂的水溶液代替卵磷脂溶液,也可以进行同样的亲水性处理。In addition, an aqueous solution of a surfactant such as glycol alkyl ether (TritonX-100) may be used instead of the lecithin solution, and the same hydrophilic treatment may be performed.

以图10虚线所示的位置关系接合如上获得的盖部件601、隔板602、第2部件102和第3部件103,组装测定仪器600。接合方法与实施方式1相同,因此省略。The lid member 601, spacer 602, second member 102, and third member 103 obtained above are joined in the positional relationship shown by the dotted line in FIG. 10, and the measuring instrument 600 is assembled. The joining method is the same as that of Embodiment 1, so it is omitted.

2.测定装置2. Measuring device

接着,使用图11和5说明本实施方式的测定装置800。图11为表示本实施方式的测定装置的立体图。另外,与图4所示实施方式1的测定装置共同的构成带有相同符号,并省略说明。Next, the measuring device 800 of this embodiment will be described using FIGS. 11 and 5 . FIG. 11 is a perspective view showing the measurement device of this embodiment. In addition, components common to those of the measurement device according to Embodiment 1 shown in FIG. 4 are denoted by the same reference numerals, and description thereof will be omitted.

本实施方式的测定装置800通过可装卸地接合于测定仪器600的第2抽吸口109侧的端部而可以将测定仪器600安装在测定装置800上。测定仪器安装部301具有仪器安装口(未图示),并设有显示测定结果的显示部302、试样抽吸开始按钮303和测定仪器取出按钮304。The measurement device 800 of this embodiment can attach the measurement device 600 to the measurement device 800 by detachably joining the end portion of the measurement device 600 on the second suction port 109 side. The measuring instrument mounting portion 301 has an instrument mounting port (not shown), and is provided with a display portion 302 for displaying measurement results, a sample suction start button 303 , and a measuring instrument take-out button 304 .

在仪器安装口的内侧设有凸部,在安装测定仪器600时,凸部插入到第2抽吸口109中。此时,优选与实施方式1同样,例如将特氟隆(注册商标)或异戊二烯橡胶等具有弹性的树脂制密封环设置在上述凸部的周围,以使得不发生接合部的空气泄漏,从而提高凸部和第2抽吸口109的密合性。A convex portion is provided inside the instrument mounting port, and the convex portion is inserted into the second suction port 109 when the measuring instrument 600 is mounted. In this case, similarly to Embodiment 1, for example, an elastic resin seal ring such as Teflon (registered trademark) or isoprene rubber is preferably provided around the protrusion so that air leakage does not occur at the junction. , thereby improving the adhesion between the convex portion and the second suction port 109 .

由于测定装置800的内部结构与实施方式1相同,因此省略说明。Since the internal structure of the measurement device 800 is the same as that of Embodiment 1, description thereof will be omitted.

3.测定方法3. Measurement method

接着,参照图11和5说明使用本实施方式的测定仪器来测定试样中的待测物质的方法。以下对使用尿作为试样的例子进行说明。Next, a method of measuring a test substance in a sample using the measuring device of this embodiment will be described with reference to FIGS. 11 and 5 . An example using urine as a sample will be described below.

首先,按照测定仪器600的第2抽吸口109接合于测定装置800的测定仪器安装部301的方式来安装测定仪器600。由此,按照与测定仪器600的2个电极201a、202a电导通的方式,连接部201b、202b与设置在测定仪器安装部301内部的2个端子分别相接触。First, the measuring instrument 600 is mounted so that the second suction port 109 of the measuring instrument 600 is joined to the measuring instrument mounting portion 301 of the measuring device 800 . Thereby, the connection parts 201b, 202b contact the two terminals provided inside the measuring instrument mounting part 301 so as to electrically conduct with the two electrodes 201a, 202a of the measuring instrument 600, respectively.

此时,设置在测定装置800内的由微开关构成的测定仪器插入感知开关(未图示)工作,作为控制部发挥功能的CPU401感知到测定仪器600的插入,通过电压施加部402在测定仪器600的2个电极201a、202a之间施加电压(例如电极201a相比于电极202a为+0.2V的电压)。At this time, a measuring instrument insertion sensing switch (not shown) constituted by a microswitch provided in the measuring device 800 operates, and the CPU 401 functioning as a control unit senses the insertion of the measuring instrument 600, and the measuring instrument 600 is inserted through the voltage applying unit 402. A voltage is applied between the two electrodes 201a and 202a of 600 (for example, the electrode 201a has a voltage of +0.2V compared to the electrode 202a).

另外,本实施方式的情况为空气孔603不会被测定装置800的框体堵塞的情况。In addition, in the present embodiment, the air hole 603 is not blocked by the housing of the measurement device 800 .

接着,将测定仪器600中至少第1试样供给口105和第2试样供给口108浸渍于采集在设置于便器内的接尿容器或纸杯等可搬运容器内的尿中。由此,通过毛细管现象将试样由第1试样供给口105引入到第1容器104中。Next, at least the first sample supply port 105 and the second sample supply port 108 in the measuring device 600 are immersed in the urine collected in a portable container such as a urine container or a paper cup installed in the toilet. Thus, the sample is introduced into the first container 104 from the first sample supply port 105 by capillary action.

此时,第1容器104内的空气从空气孔603排出,同时试样充满了第1容器104至空气孔603附近。本实施方式中,由于对第3部件103、盖部件601和狭缝604内表面实施了亲水处理,因此可以将试样顺畅且均匀地供给至第1容器104内。At this time, the air in the first container 104 is discharged from the air hole 603 , and at the same time, the sample fills the first container 104 to the vicinity of the air hole 603 . In this embodiment, since the inner surfaces of the third member 103 , the cover member 601 , and the slit 604 are hydrophilically treated, the sample can be smoothly and uniformly supplied into the first container 104 .

当供给至第1容器104内的尿到达施加有电压的2个电极201a、202a时,电流在两电极间流动,因而电信号测定部405感知由此引起的电信号的变化。通过该感知,CPU401判断第1试样供给口105和第2试样供给口108浸渍于试样中,然后使活塞机构404工作。When the urine supplied into the first container 104 reaches the two electrodes 201a and 202a to which a voltage is applied, an electric current flows between the two electrodes, and the electric signal measuring unit 405 detects a change in the electric signal caused thereby. Based on this perception, the CPU 401 determines that the first sample supply port 105 and the second sample supply port 108 are immersed in the sample, and then operates the piston mechanism 404 .

由此,活塞机构404内的活塞移动,将规定量(例如3mL)的尿从测定仪器600的第2试样供给口108抽吸至第2容器107内。通过将活塞保持在该位置,尿被保持在第2容器107内,不会发生从第2试样供给口108漏出、也不会被抽吸至活塞机构404内部。As a result, the piston in the piston mechanism 404 moves, and a predetermined amount (for example, 3 mL) of urine is sucked from the second sample supply port 108 of the measuring device 600 into the second container 107 . By holding the piston at this position, urine is held in the second container 107 and does not leak from the second sample supply port 108 or be sucked into the piston mechanism 404 .

另外,伴随着该感知,CPU401开始利用作为计时部406的计时器进行计时。另外,伴随着上述感知,CPU401阻断电压施加部402所施加的电压。当开始利用计时器进行计时时,则显示部302显示计时开始。该显示后,可以将第1试样供给口105和第2试样供给口108从尿中提起。In addition, following this perception, the CPU 401 starts counting time by the timer as the timer unit 406 . In addition, the CPU 401 blocks the voltage applied by the voltage applying unit 402 following the above-mentioned sensing. When the timer starts counting, the display unit 302 displays that the counting is started. After this display, the first sample supply port 105 and the second sample supply port 108 can be lifted out of the urine.

供给至第2容器107内的尿将附载于试剂保持部110的干燥状态的试剂即抗人白蛋白抗体溶解,发生尿中抗原即人白蛋白与抗人白蛋白抗体的免疫反应。The urine supplied into the second container 107 dissolves the anti-human albumin antibody, which is the dry reagent carried on the reagent holding unit 110, and an immune reaction between the human albumin, which is an antigen in urine, and the anti-human albumin antibody occurs.

接着,根据来自计时部406的信号,CPU401判断尿到达电极201a、202a后经过规定时间(例如2分钟),则CPU401实施利用光源407的光照射和利用电压施加部402的电压施加(例如电极201a相比于电极202a为+0.5V的电压)。Then, according to the signal from the timer unit 406, the CPU 401 judges that a predetermined time (for example, 2 minutes) has elapsed since the urine reached the electrodes 201a and 202a, and then the CPU 401 implements light irradiation by the light source 407 and voltage application by the voltage application unit 402 (for example, the electrode 201a A voltage of +0.5V compared to electrode 202a).

之后的使用由受光器408接受的出射光强度的人白蛋白浓度测定、使用利用电信号测定部405测定的电信号的葡萄糖浓度测定的顺序等与实施方式1相同,因此省略说明。The subsequent steps of measuring the concentration of human albumin using the intensity of emitted light received by the photoreceiver 408 and measuring the glucose concentration using the electrical signal measured by the electrical signal measuring unit 405 are the same as those in Embodiment 1, and therefore description thereof will be omitted.

如上所述,通过将试样1次供给至第1容器104和第2容器107内,与实施方式1同样,可以使用1个测定仪器600来进行试样的光学测定和电化学测定。As described above, by supplying the sample once into the first container 104 and the second container 107 , as in the first embodiment, optical measurement and electrochemical measurement of the sample can be performed using one measuring instrument 600 .

通过在测定仪器600的第1容器104内设置电极201a、202a,在第2容器107内设置试剂保持部110,光学测定所需要的试剂不会扩散至电化学测定部,不会对电化学测定造成影响,因此可以对多个测定项目迅速且正确地进行测定。By providing the electrodes 201a, 202a in the first container 104 of the measuring instrument 600, and providing the reagent holding part 110 in the second container 107, the reagents required for the optical measurement will not diffuse into the electrochemical measurement part and will not affect the electrochemical measurement. Since it is affected, multiple measurement items can be quickly and accurately measured.

另外,使第1容器104为空腔结构、将试样通过毛细管现象从第1试样供给口105供给至第1容器104内,因此根据来自电极201a、202a的电信号变化,可以感知到第1试样供给口105和第2试样供给口108浸渍于试样中。通过伴随着该感知使活塞机构404自动地工作,可以防止在第2试样供给口108接触于试样之前错误地发生试样的抽吸。In addition, since the first container 104 has a cavity structure and the sample is supplied into the first container 104 from the first sample supply port 105 by capillary phenomenon, the first sample can be sensed based on the change of the electrical signal from the electrodes 201a and 202a. The first sample supply port 105 and the second sample supply port 108 are immersed in the sample. By automatically actuating the piston mechanism 404 in response to this sensing, it is possible to prevent erroneous suction of the sample before the second sample supply port 108 comes into contact with the sample.

另外,由于可以省略按下试样抽吸开始按钮303的操作,因此可以减少使用者的操作。另外,测定装置800还可以不具备试样抽吸开始按钮303。In addition, since the operation of pressing the sample suction start button 303 can be omitted, the user's operations can be reduced. In addition, the measurement device 800 may not include the sample suction start button 303 .

在本实施方式中,通过使用模具的成型来制作盖部件601的空气孔603,但也可以通过成型制作没有空气孔603的板状盖部件601后通过切削或打孔等形成空气孔603来代替它。In this embodiment, the air holes 603 of the cover member 601 are formed by molding using a mold, but instead of forming the air holes 603 by cutting or punching, the plate-shaped cover member 601 without the air holes 603 may be formed by molding. it.

另外,对第3部件103和盖部件601的表面以及狭缝604的内表面实施了亲水性处理,以使得第1容器104的内表面具有亲水性,但也可以利用具有亲水性的材料形成第3部件103、盖部件601和隔板602来代替它。作为具有亲水性的材料,例如可以举出玻璃等。In addition, the surface of the third member 103 and the cover member 601 and the inner surface of the slit 604 are subjected to a hydrophilic treatment so that the inner surface of the first container 104 becomes hydrophilic, but a hydrophilic material may also be used. The material forms the third member 103, the cover member 601 and the spacer 602 instead. As a material which has hydrophilicity, glass etc. are mentioned, for example.

而且,在本实施方式中,为了形成第1容器104,使用了设置有狭缝604的隔板602,但并非局限于此。图12为表示本实施方式的测定仪器的变形例的分解立体图。对于与图10同样的构成带有相同符号,并省略说明。Moreover, in this embodiment, in order to form the 1st container 104, the partition plate 602 provided with the slit 604 was used, but it is not limited to this. Fig. 12 is an exploded perspective view showing a modified example of the measuring instrument of the present embodiment. The same symbols are assigned to the same configuration as in FIG. 10 , and description thereof will be omitted.

如图12所示,作为隔板602,可以使用2根矩形状(轨道状)的板部件。此时,盖部件601还可以不具备空气孔603。通过组合盖部件601、隔板602和第3部件103,形成两端开放的空间,与第1试样供给口105相反侧的开口部作为空气孔603发挥功能。As shown in FIG. 12 , two rectangular (rail-shaped) plate members can be used as the separator 602 . In this case, the cover member 601 may not have the air holes 603 . By combining the lid member 601 , the spacer 602 , and the third member 103 , a space with open ends is formed, and the opening on the opposite side to the first sample supply port 105 functions as an air hole 603 .

对于测定仪器600的形状,只要是满足本发明的构成要件、且可以获得本申请发明的效果即可,并非局限于上述实施方式。图13为表示本实施方式的测定仪器的变形例的立体图、图14为图13的D-D剖面图。与图1相同的构成带有相同符号,并省略说明。The shape of the measuring device 600 is not limited to the above-mentioned embodiment as long as it satisfies the constituent requirements of the present invention and can obtain the effects of the present invention. FIG. 13 is a perspective view showing a modified example of the measuring instrument of the present embodiment, and FIG. 14 is a cross-sectional view along line D-D of FIG. 13 . The same components as those in Fig. 1 are assigned the same symbols, and description thereof will be omitted.

如图13和图14所示,本变形例的测定仪器600具有组合了内部具有作为第1容器104发挥功能的空间的第1长方体和内部具有作为第2容器107发挥功能的空间且小于第1长方体的第2长方体而成的形状。另外,本变形例的测定仪器600具有第2部件102、盖部件601、隔板602和第3部件103,在盖部件601和第2部件102的侧面分别设有第1试样供给口105和第2试样供给口108。As shown in FIGS. 13 and 14 , the measuring instrument 600 of this modified example has a combination of a first cuboid having a space functioning as the first container 104 inside and a space smaller than the first container having a space functioning as the second container 107 inside. The shape formed by the second cuboid of the cuboid. In addition, the measuring instrument 600 of this modified example has a second member 102, a cover member 601, a spacer 602, and a third member 103, and a first sample supply port 105 and a first sample supply port 105 are respectively provided on the side surfaces of the cover member 601 and the second member 102. The second sample supply port 108 .

[实施方式3][Embodiment 3]

接着说明本发明的测定仪器的实施方式3。在本实施方式中,与实施方式1同样,对试样为尿、第1待测物质为人白蛋白、第2待测物质为葡萄糖的情况进行说明。Next, Embodiment 3 of the measurement device of the present invention will be described. In this embodiment, as in Embodiment 1, a case where the sample is urine, the first analyte is human albumin, and the second analyte is glucose will be described.

首先,使用图15~18说明本实施方式的测定仪器700的结构。图15为表示本实施方式的测定仪器700的立体图,图16为图15的E-E剖面图。图17为本实施方式的测定仪器700的俯视图、图18为测定仪器700的分解立体图。对于与图1~3所示的构成要素共同的构成要素使用相同的符号,并省略说明。First, the structure of the measuring instrument 700 of this embodiment is demonstrated using FIGS. 15-18. FIG. 15 is a perspective view showing a measuring instrument 700 according to this embodiment, and FIG. 16 is a cross-sectional view taken along line E-E of FIG. 15 . FIG. 17 is a plan view of a measuring device 700 according to this embodiment, and FIG. 18 is an exploded perspective view of the measuring device 700 . The same reference numerals are used for components common to those shown in FIGS. 1 to 3 , and explanations thereof are omitted.

本实施方式的测定仪器700具备透明聚苯乙烯制的第1部件701、第2部件702和第3部件703。第1部件701的外表面由3个面701a、701b、701c构成。第1面701c上设有第1试样供给口105。The measuring instrument 700 of the present embodiment includes a first member 701 , a second member 702 , and a third member 703 made of transparent polystyrene. The outer surface of the first member 701 is composed of three surfaces 701a, 701b, and 701c. The first sample supply port 105 is provided on the first surface 701c.

以图18虚线所示的位置关系组合第1部件701、第2部件702和第3部件703,第3部件703成为隔板而形成2个空间。在2个空间中,与第1试样供给口105连通的空间作为第1容器104发挥功能,另一个空间作为第2容器107发挥功能。The first member 701, the second member 702, and the third member 703 are combined in the positional relationship shown by the dotted line in FIG. 18, and the third member 703 serves as a partition to form two spaces. Of the two spaces, the space communicating with the first sample supply port 105 functions as the first container 104 , and the other space functions as the second container 107 .

第3部件703在四边形板状部件的中央部分具有连通第1容器104和第2容器107的开口部705。开口部705具有作为实施方式1的测定仪器100的第1抽吸口106和第2试样供给口108的功能。另外,在第3部件703的中心具有按照覆盖第2容器107侧的开口部705的方式防止倒流用的阀704,可以防止从第2容器107向第1容器104的倒流。The third member 703 has an opening 705 in the center of the rectangular plate-shaped member that communicates with the first container 104 and the second container 107 . The opening 705 functions as the first suction port 106 and the second sample supply port 108 of the measuring instrument 100 according to the first embodiment. In addition, a backflow prevention valve 704 is provided at the center of the third member 703 so as to cover the opening 705 on the second container 107 side, thereby preventing backflow from the second container 107 to the first container 104 .

在第2部件702的内壁面720b上设有一对导电部201、202。一对导电部201、202的一部分被由绝缘性树脂构成的盖子203覆盖。在一对导电部中,露出至第1容器104内的部分作为一对电极201a、202a发挥功能,露出至第2容器107内的部分作为一对连接部201b、202b发挥功能。A pair of conductive parts 201 and 202 are provided on the inner wall surface 720b of the second member 702 . A part of the pair of conductive parts 201 and 202 is covered with a cover 203 made of insulating resin. Of the pair of conductive parts, the part exposed into the first container 104 functions as a pair of electrodes 201a, 202a, and the part exposed into the second container 107 functions as a pair of connecting parts 201b, 202b.

第1部件701、第2部件702的尺寸例如可以均是宽度(图18的A)为10mm、长度(图18的B)为84mm、厚度为1mm。The dimensions of the first member 701 and the second member 702 may be, for example, 10 mm in width (A in FIG. 18 ), 84 mm in length (B in FIG. 18 ), and 1 mm in thickness.

另外,第1部件701和第2部件702的高度(图18的C)例如可以均为3.5mm。In addition, the heights (C of FIG. 18 ) of the first member 701 and the second member 702 may both be 3.5 mm, for example.

而且,在第2容器107内的第2部件702的内壁面702a上设有保持用于光学测定的试剂的试剂保持部110。Further, a reagent holding portion 110 for holding a reagent for optical measurement is provided on the inner wall surface 702a of the second member 702 in the second container 107 .

第1部件701的外表面由3个面701a、701b和701c构成,在处于相对位置的2个面701a、701b中的一个面中,包围第2容器107的部分作为光入射部111发挥功能,另一面中包围第2容器107的部分作为光出射部112发挥功能。光入射部111和光出射部112相当于本发明的光学测定部。The outer surface of the first member 701 is composed of three surfaces 701a, 701b, and 701c, and on one of the two surfaces 701a, 701b that are positioned opposite each other, the portion surrounding the second container 107 functions as the light incident portion 111, A portion surrounding the second container 107 on the other surface functions as the light emitting portion 112 . The light incident part 111 and the light emitting part 112 correspond to the optical measurement part of this invention.

接着,使用图18说明本实施方式的测定仪器700的制作方法。图18为本实施方式的测定仪器700的分解立体图。Next, a method of manufacturing the measurement device 700 of this embodiment will be described using FIG. 18 . FIG. 18 is an exploded perspective view of a measuring instrument 700 according to this embodiment.

与实施方式1相同,第1部件701、第2部件702和第3部件703为透明的聚苯乙烯制,可以通过使用模具的成型而获得。Like Embodiment 1, the first member 701, the second member 702, and the third member 703 are made of transparent polystyrene and can be obtained by molding using a mold.

接着,在第3部件703的第2容器107侧的面上按照覆盖开口部705的方式配置阀704。阀704优选由天然橡胶或合成橡胶等具有柔软性的树脂构成。使由树脂构成的阀704的周缘部的一部分粘接于第3部件703、剩余部分不粘接,在第3部件703的第2容器107侧的面上按照覆盖开口部705的方式安装阀704。由此,试样从第1容器104经过开口部705和阀704中未与第3部件703粘接的部分流入到第2容器107中。更具体地说,当试样由第1试样供给口105供给至第1容器104中时,所供给的试样从下方挤压阀704,阀704的未粘接的部分被挤压至上方,如图19所示,阀704发生变形。由此,试样可以按照箭头所示的方向流入,试样被供给至第2容器107内。与此相对,试样不会流入与图19中箭头方向相反的方向,即试样不会从第2容器107内流入到第1容器104内。这样阀704作为防止倒流的阀发挥功能。Next, the valve 704 is arranged on the surface of the third member 703 on the second container 107 side so as to cover the opening 705 . The valve 704 is preferably made of a flexible resin such as natural rubber or synthetic rubber. Part of the periphery of the valve 704 made of resin is bonded to the third member 703, and the remaining part is not bonded, and the valve 704 is attached to the surface of the third member 703 on the second container 107 side so as to cover the opening 705. . Thus, the sample flows from the first container 104 into the second container 107 through the opening 705 and the portion of the valve 704 that is not bonded to the third member 703 . More specifically, when a sample is supplied into the first container 104 from the first sample supply port 105, the supplied sample presses the valve 704 from below, and the unbonded part of the valve 704 is pressed to the top. , as shown in FIG. 19, the valve 704 is deformed. Thus, the sample can flow in the direction indicated by the arrow, and the sample is supplied into the second container 107 . On the other hand, the sample does not flow in the direction opposite to the arrow direction in FIG. 19 , that is, the sample does not flow from the second container 107 into the first container 104 . In this way, the valve 704 functions as a valve for preventing backflow.

接着,在第2部件702的面702a上形成试剂保持部110。试剂保持部110的形成方法与实施方式1相同,因此省略。Next, the reagent holding portion 110 is formed on the surface 702 a of the second member 702 . The method of forming the reagent holding portion 110 is the same as that in Embodiment 1, so it is omitted.

进而,在第2部件702的凹部底面702b上形成一对导电部201、202和盖子203。导电部201、202和盖子203的形成方法与实施方式1相同,因此省略说明。Furthermore, a pair of conductive parts 201 and 202 and a cover 203 are formed on the concave bottom surface 702b of the second member 702 . The method of forming the conductive parts 201 and 202 and the cover 203 is the same as that of Embodiment 1, and thus description thereof will be omitted.

以图18虚线所示的位置关系接合如上获得的第1部件701、第2部件702和第3部件703,组合测定仪器700。接合方法与实施方式1相同,因此省略。The first member 701, the second member 702, and the third member 703 obtained above are joined in the positional relationship shown by the dotted line in FIG. 18, and the measuring instrument 700 is assembled. The joining method is the same as that of Embodiment 1, so it is omitted.

2.测定装置2. Measuring device

接着,使用图20和图21说明本实施方式的测定装置900。图20为表示本实施方式的测定装置的立体图。图21为表示本实施方式的测定装置的构成的模块图。对于与图4和图5所示的构成共同的构成要素使用相同的符号,并省略说明。Next, the measurement device 900 according to this embodiment will be described using FIGS. 20 and 21 . Fig. 20 is a perspective view showing the measurement device of the present embodiment. FIG. 21 is a block diagram showing the configuration of the measurement device according to this embodiment. Components common to those shown in FIGS. 4 and 5 are denoted by the same reference numerals, and description thereof will be omitted.

本实施方式的测定装置900通过以可装卸的方式接合于实施方式1的测定装置的测定仪器700的第2抽吸口109侧的端部而可以将测定仪器700安装于测定装置900。测定仪器安装部901具有仪器安装口(未图示),并设有显示测定结果的显示部902和试样抽吸开始按钮903。The measurement device 900 of the present embodiment can attach the measurement device 700 to the measurement device 900 by detachably joining the end portion of the measurement device 700 of the measurement device of the first embodiment on the second suction port 109 side. The measuring instrument mounting portion 901 has an instrument mounting port (not shown), and is provided with a display portion 902 for displaying measurement results and a sample suction start button 903 .

仪器安装口的内侧设有凸部,在安装测定仪器700时将凸部插入到第2抽吸口109中。此时,优选与实施方式1同样,将例如特氟隆(注册商标)或异戊二烯橡胶等具有弹性的树脂制密封环设置在上述凸部的周围,以使得不会发生接合部的空气泄漏,从而提高凸部和第2抽吸口109的密合性。A convex portion is provided inside the instrument mounting port, and the convex portion is inserted into the second suction port 109 when the measuring instrument 700 is mounted. At this time, like Embodiment 1, it is preferable to provide an elastic resin seal ring such as Teflon (registered trademark) or isoprene rubber around the above-mentioned convex portion so that air in the joint portion does not occur. Leakage improves the adhesion between the convex portion and the second suction port 109 .

如图21所示,测定装置900的内部结构为从实施方式1的图4所示的测定装置的构成中除去测定仪器取出机构401和测定仪器取出按钮304的构成。As shown in FIG. 21 , the internal configuration of the measuring device 900 is a configuration in which the measuring device taking out mechanism 401 and the measuring device taking out button 304 are removed from the configuration of the measuring device shown in FIG. 4 of the first embodiment.

3.测定方法3. Measurement method

接着,参照图20和21说明使用本实施方式的测定仪器700和测定装置900来测定试样中的待测物质的方法。以下对使用尿作为试样的例子进行说明。Next, a method of measuring a test substance in a sample using the measuring device 700 and the measuring device 900 of this embodiment will be described with reference to FIGS. 20 and 21 . An example using urine as a sample will be described below.

首先,将测定仪器700的第2抽吸口109接合于测定仪器安装部901内的仪器安装口(未图示),将测定仪器700安装在测定仪器安装部901上。由此,按照与测定仪器700的2个电极201a、202a电导通的方式,连接部201b、202b与设置在测定仪器安装部901内部的2个端子分别相接触。First, the second suction port 109 of the measuring instrument 700 is connected to the instrument mounting port (not shown) in the measuring instrument mounting part 901 , and the measuring instrument 700 is mounted on the measuring device mounting part 901 . Thereby, the connection parts 201b, 202b contact the two terminals provided inside the measuring instrument mounting part 901 so as to electrically conduct with the two electrodes 201a, 202a of the measuring instrument 700, respectively.

此时,设置在测定装置900内的由微开关构成的测定仪器插入感知开关(未图示)工作,作为控制部发挥功能的CPU401感知到测定仪器700的插入,通过电压施加部402在测定仪器700的2个电极201a、202a之间施加电压(例如电极201a相比于电极202a为+0.2V的电压)。At this time, a measuring instrument insertion detection switch (not shown) constituted by a microswitch provided in the measuring device 900 operates, and the CPU 401 functioning as a control unit senses the insertion of the measuring instrument 700, and the measuring instrument 700 is inserted through the voltage applying unit 402. A voltage is applied between the two electrodes 201a and 202a of 700 (for example, the electrode 201a has a voltage of +0.2V compared to the electrode 202a).

接着,将测定仪器700浸渍于例如收集在设置于便盆内的接尿容器或纸杯等可搬运容器的尿中,至少达到基准线115的位置,将测定仪器700的第1试样供给口105浸渍于尿中。Next, the measuring instrument 700 is immersed in urine collected in a portable container such as a urine container or a paper cup installed in the toilet, at least up to the position of the reference line 115, and the first sample supply port 105 of the measuring instrument 700 is immersed. in the urine.

这里,使用者确认至少第1试样供给口105浸渍于尿中,在此状态下按下试样抽吸开始按钮903,使设于测定装置900内的抽吸手段的一部分即活塞机构404工作,由此,活塞机构404内的活塞移动,将尿从测定仪器700的第1试样供给口105抽吸至第1容器104中。Here, the user confirms that at least the first sample supply port 105 is immersed in urine, presses the sample suction start button 903 in this state, and operates the piston mechanism 404 which is a part of the suction means provided in the measuring device 900. Accordingly, the piston in the piston mechanism 404 moves to suck urine from the first sample supply port 105 of the measuring instrument 700 into the first container 104 .

当供给至第1容器104内的尿接触于电极201a、202a时,由于电流在两电极间流动,因此电信号测定部405感知由此所引起的电信号的变化。When the urine supplied into the first container 104 comes into contact with the electrodes 201a and 202a, since a current flows between the two electrodes, the electrical signal measuring unit 405 detects a change in the electrical signal caused by this.

伴随着该感知,CPU401开始利用作为计时部406的计时器进行计时。另外,伴随着上述感知,CPU401阻断电压施加部402所施加的电压。当开始利用计时器进行计时时,则显示部902显示计时开始。Accompanied by this perception, the CPU 401 starts counting time by the timer as the timer unit 406 . In addition, the CPU 401 blocks the voltage applied by the voltage applying unit 402 following the above-mentioned sensing. When the timer starts counting, the display unit 902 displays that the counting is started.

尿介由图19所示的阀704的变形所产生的阀704与第3部件703之间的间隙和开口部705供给至第2容器107内。此时,通过阀704,防止供给至第2容器107的尿倒流至第1容器104内。Urine is supplied into the second container 107 through the gap between the valve 704 and the third member 703 and the opening 705 caused by the deformation of the valve 704 shown in FIG. 19 . At this time, the urine supplied to the second container 107 is prevented from flowing back into the first container 104 by the valve 704 .

接着,根据来自计时部406的信号,CPU401判断尿到达电极201a、202a后经过规定时间(例如30秒钟)、规定量的尿被供给至第2容器107内时,CPU401停止利用活塞机构404进行的尿的抽吸。Next, based on the signal from the timer unit 406, the CPU 401 judges that a predetermined time (for example, 30 seconds) has elapsed since the urine reached the electrodes 201a and 202a, and when a predetermined amount of urine has been supplied into the second container 107, the CPU 401 stops using the piston mechanism 404. suction of urine.

此时,通过将活塞保持在抽吸试样时的位置上,尿被保持在第1容器104和第2容器107内,不会从第1试样供给口105漏出、也不会被抽吸至活塞机构404内部。At this time, by holding the piston at the position where the sample is sucked, the urine is held in the first container 104 and the second container 107, and will not leak from the first sample supply port 105 or be sucked. to the inside of the piston mechanism 404 .

被供给至第2容器107内的尿将附载于试剂保持部110的干燥状态的试剂即抗人白蛋白抗体溶解,发生尿中抗原即人白蛋白和抗人白蛋白抗体的免疫反应。The urine supplied into the second container 107 dissolves the anti-human albumin antibody, which is the dry reagent carried on the reagent holding unit 110, and an immune reaction between human albumin, which is an antigen in urine, and the anti-human albumin antibody occurs.

接着,通过来自计时部406的信号,当CPU401判断尿到达电极201a、202a经过第2个规定时间(例如2分钟)时,CPU401实施利用光源407的光照射和利用电压施加部402的电压施加(例如电极201a与电极202a相比为+0.5V的电压)。Next, when the CPU 401 judges that the urine has reached the electrodes 201a and 202a by the signal from the timer unit 406, the second predetermined time (for example, 2 minutes) has elapsed, the CPU 401 executes light irradiation by the light source 407 and voltage application by the voltage application unit 402 ( For example, electrode 201a has a voltage of +0.5V compared to electrode 202a).

通过设置于测定装置900内的受光器408,在规定时间内(例如3分钟)接受从光源407发出、通过测定仪器700的光入射部111入射到第2容器107内、在尿中透射和散射、从光出射部112射出的光。这里,如图17和18所示,将测定仪器700的第1部件701的面701b中包围第2容器107的部分作为光入射部111,将测定仪器700的第1部件701的面701a中包围第2容器107的部分作为光出射部112。The photoreceiver 408 installed in the measuring device 900 accepts the light emitted from the light source 407 and incident into the second container 107 through the light incident part 111 of the measuring instrument 700 within a predetermined time period (for example, 3 minutes), and is transmitted and scattered in urine. , the light emitted from the light emitting portion 112 . Here, as shown in FIGS. 17 and 18 , the portion surrounding the second container 107 in the surface 701b of the first member 701 of the measuring instrument 700 is used as the light incident portion 111, and the portion surrounding the surface 701a of the first member 701 of the measuring instrument 700 A portion of the second container 107 serves as the light emitting portion 112 .

CPU401读取存储于存储器409中的与表示出射光强度和人白蛋白浓度关系的第1校准曲线相关的数据,参照该第1校准曲线,CPU401将由受光器408接受的出射光强度换算为人白蛋白浓度。The CPU 401 reads the data related to the first calibration curve representing the relationship between the intensity of the emitted light and the concentration of human albumin stored in the memory 409. Referring to the first calibration curve, the CPU 401 converts the intensity of the emitted light received by the light receiver 408 into human albumin. concentration.

所得人白蛋白浓度显示于显示部902中。通过在显示部902中显示人白蛋白,使用者可知人白蛋白浓度测定完成。The obtained concentration of human albumin is displayed on the display unit 902 . By displaying human albumin on the display unit 902, the user can know that the measurement of the concentration of human albumin is completed.

另一方面,根据来自计时部406的信号,当CPU401判断施加上述电压后经过规定时间(例如1分钟)时,通过电信号测定部405测定在电极201a和电极202a之间流动的电流等电信号。CPU401读取存储于存储器409中的与表示电信号和葡萄糖(尿糖)浓度关系的第2校准曲线相关的数据,参照该数据,CPU401将测定的电信号换算为尿中的葡萄糖浓度。On the other hand, when the CPU 401 judges that a predetermined time (for example, 1 minute) has elapsed after the application of the voltage based on the signal from the timer unit 406, an electrical signal such as a current flowing between the electrode 201a and the electrode 202a is measured by the electrical signal measuring unit 405. . CPU 401 reads data related to the second calibration curve representing the relationship between the electrical signal and glucose (urine sugar) concentration stored in memory 409 , and refers to the data to convert the measured electrical signal into urine glucose concentration.

所得葡萄糖浓度显示于显示部902中。通过在显示部902中显示葡萄糖浓度,使用者可知葡萄糖浓度测定完成。优选所得葡萄糖浓度和人白蛋白浓度与计时部406所计时的时刻一起保存于存储器409中。The obtained glucose concentration is displayed on the display unit 902 . By displaying the glucose concentration on the display unit 902, the user can know that the glucose concentration measurement has been completed. The obtained glucose concentration and human albumin concentration are preferably stored in the memory 409 together with the time counted by the timer unit 406 .

最后,使用者手动地将测定仪器700从测定仪器安装部901取出。Finally, the user manually removes the measuring instrument 700 from the measuring instrument mounting part 901 .

上述实施方式中参照的图3、图8、图10、图12、图13、图15和图18中,对于导电部201、202、电极201a、202a、连接部201b、202b和盖子203,是忽略了它们的厚度来表示的。在图18中,对于阀704和试剂保持部110也是忽略了它们的厚度来表示的。3, FIG. 8, FIG. 10, FIG. 12, FIG. 13, FIG. 15 and FIG. Ignored their thickness to represent. In FIG. 18 , the valve 704 and the reagent holding part 110 are also shown with their thicknesses omitted.

另外,在以上实施方式中,通过涂覆含有用于光学测定的试剂的水溶液后进行干燥而形成试剂保持部,但也可以使用下述方法来代替它:使玻璃纤维或滤纸等多孔性载体浸渍于试剂的溶液中后使其干燥或冷冻干燥,从而使试剂附载,然后通过将该多孔性载体粘贴在第2部件102的凹部底面而附载试剂。In addition, in the above embodiments, the reagent holding part is formed by coating an aqueous solution containing a reagent for optical measurement and then drying it, but a method of impregnating a porous carrier such as glass fiber or filter paper may be used instead. The reagent is loaded by drying or freeze-drying in a solution of the reagent, and then the porous carrier is pasted on the bottom surface of the concave part of the second member 102 to load the reagent.

另外,通过溅射或蒸镀形成了电极,但也可以使用粘贴金属带的方法或者印刷含有金属或碳的油墨的方法等来代替它。这些情况下可以与电极一起同时制作用于实现各电极和测定装置的电连接的导线。In addition, the electrodes are formed by sputtering or vapor deposition, but a method of affixing a metal tape or a method of printing an ink containing metal or carbon may be used instead. In these cases, lead wires for electrical connection between the electrodes and the measurement device can be produced simultaneously with the electrodes.

而且,在以上的实施方式中,随着感知到尿接触于2个电极201a、202a,暂时阻断电压,在再次施加电压时切换电压值,但并非必须进行切换。只要是在供给试样前开始施加测定所必需的电压值,则也可以在供给后继续施加该电压。Furthermore, in the above embodiments, the voltage is temporarily blocked when urine is sensed to be in contact with the two electrodes 201a and 202a, and the voltage value is switched when the voltage is reapplied, but the switching is not necessarily required. As long as the application of the voltage necessary for the measurement is started before the sample is supplied, the application of the voltage may be continued after the supply.

另外,在以上的实施方式中,在感知尿接触于2个电极201a、202a后,经过规定时间后进行光的照射,但还可以与试样感知同时地开始照射。In addition, in the above embodiments, light irradiation is performed after a predetermined time elapses after sensing that urine has come into contact with the two electrodes 201a and 202a, but irradiation may also be started simultaneously with sample sensing.

根据本发明,可以提供通过进行试样的光学测定和电化学测定,能够以简单的构成对多个测定项目迅速且正确地进行测定的测定仪器、测定装置和测定方法,因此在医疗和医疗相关的检查领域中、特别是测定尿检体的情况下是有用的。According to the present invention, it is possible to provide a measuring instrument, a measuring device, and a measuring method that can quickly and accurately measure a plurality of measurement items with a simple configuration by performing optical measurement and electrochemical measurement of a sample. It is useful in the field of inspection, especially in the case of measuring urine samples.

权利要求书(按照条约第19条的修改)Claims (as amended under Article 19 of the Treaty)

1.(修改后)用于分析试样中所含的待测物质的测定仪器,其具备:用于保持含有待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;1. (After revision) A measuring instrument for analyzing a test substance contained in a sample, comprising: a first container and a second container for holding a sample containing the test substance; an optical measurement unit for optically measuring the sample in the second container;

所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;The first container has a first sample supply port and an electrode for supplying the sample into the first container;

所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部;The second container includes a second sample supply port for supplying the sample into the second container, and a reagent holding portion for holding a reagent for the optical measurement;

所述第2容器不具备电极。The second container does not include electrodes.

2.权利要求1所述的测定仪器,其中,所述光学测定部具备:用于使入射光从所述第2容器的外部入射到内部的光入射部;和用于使出射光从所述第2容器的内部射出到外部的光出射部。2. The measuring instrument according to claim 1, wherein the optical measuring unit has: a light incident unit for making incident light incident from the outside of the second container to the inside; The inside of the second container emits light to the outside of the light emitting portion.

3.权利要求1或2所述的测定仪器,其中,所述电极为一对电极。3. The measuring instrument according to claim 1 or 2, wherein the electrodes are a pair of electrodes.

4.权利要求1所述的测定仪器,其中,所述电极上附载有酶。4. The measurement device according to claim 1, wherein an enzyme is attached to the electrode.

5.权利要求1~4任一项所述的测定仪器,其中,所述试剂含有酶或抗体。5. The measurement device according to any one of claims 1 to 4, wherein the reagent contains an enzyme or an antibody.

6.权利要求1~5任一项所述的测定仪器,其中,按照从所述第2试样供给口至所述试剂保持部的距离X与从所述第1试样供给口至所述电极的距离Y满足关系式X<Y的方式配置所述试剂保持部和所述电极。6. The measuring instrument according to any one of claims 1 to 5, wherein the distance X from the second sample supply port to the reagent holding part is the same as the distance X from the first sample supply port to the reagent holding part. The reagent holding portion and the electrodes are arranged such that the distance Y between the electrodes satisfies the relational expression X<Y.

7.权利要求1~5任一项所述的测定仪器,其中,所述第1容器还具备空气孔。7. The measuring instrument according to any one of claims 1 to 5, wherein the first container further includes an air hole.

8.用于分析试样中所含的待测物质的测定装置,其具备:用于安装权利要求1~7任一项所述的测定仪器的测定仪器安装部;用于发出从所述第2容器的外部入射到内部的入射光的光源;用于接受从所述第2容器的内部射出到外部的出射光的受光部;用于对所述电极施加电压的电压施加部;用于对来自所述电极的电信号进行测定的电信号测定部;和用于基于通过所述受光部接受的所述出射光和通过所述电信号测定部测定的所述电信号中的至少一个来对所述试样中所含的所述待测物质进行检测或定量的运算部。8. A measuring device for analyzing a substance to be measured contained in a sample, comprising: a measuring device installation part for mounting the measuring device according to any one of claims 1 to 7; 2. A light source for incident light from the outside of the container to the inside; a light receiving unit for receiving light emitted from the inside of the second container to the outside; a voltage applying unit for applying a voltage to the electrodes; an electric signal measuring unit for measuring an electric signal from the electrode; and for measuring based on at least one of the outgoing light received by the light receiving unit and the electric signal measured by the electric signal measuring unit A computing unit for detecting or quantifying the analyte contained in the sample.

9.权利要求8所述的测定装置,其中,其还具备抽吸部,该抽吸部用于通过抽吸将所述试样供给至安装于所述测定仪器安装部的所述测定仪器的所述第1容器和所述第2容器中的至少一个。9. The measuring device according to claim 8, further comprising a suction unit for supplying the sample by suction to the measuring instrument attached to the measuring instrument mounting portion. At least one of the first container and the second container.

10.使用测定仪器对试样中所含的第1待测物质和第2待测物质进行测定的方法,其中,所述测定仪器具备:用于保持含有第1待测物质和第2待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;10. A method for measuring a first analyte and a second analyte contained in a sample using a measuring instrument, wherein the measuring instrument is equipped with a method for maintaining the first analyte and the second analyte a first container and a second container for a sample of a substance, and an optical measurement unit for optically measuring the sample held in the second container;

所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;The first container has a first sample supply port and an electrode for supplying the sample into the first container;

所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部,The second container includes a second sample supply port for supplying the sample into the second container and a reagent holding portion for holding a reagent for the optical measurement,

所述测定方法包含以下工序:The assay method comprises the following steps:

(A)将所述试样通过浸渍于所述试样中的所述第1试样供给口供给至所述第1容器内的工序;(A) a step of supplying the sample into the first container through the first sample supply port immersed in the sample;

(B)将所述试样通过浸渍于所述试样中的所述第2试样供给口供给至所述第2容器内的工序;(B) a step of supplying the sample into the second container through the second sample supply port immersed in the sample;

(C)对所述电极施加电压的工序;(C) a step of applying a voltage to the electrodes;

(D)对来自所述电极的电信号进行测定的工序;(D) a step of measuring electrical signals from the electrodes;

(E)基于在所述工序(D)中测定的所述电信号来对所述第2待测物质进行检测或定量的工序;(E) a step of detecting or quantifying the second analyte based on the electrical signal measured in the step (D);

(F)将入射光通过所述光学测定部照射到保持于所述第2容器内的所述试样上的工序;(F) a step of irradiating incident light onto the sample held in the second container through the optical measurement unit;

(G)对由于所述入射光的照射而引起的从所述第2容器的内部通过所述光学测定部射出到外部的出射光进行测定的工序;(G) a step of measuring emitted light emitted from the inside of the second container through the optical measurement unit to the outside due to the irradiation of the incident light;

(H)基于在所述工序(G)中测定的所述出射光来对所述第1待测物质进行检测或定量的工序。(H) A step of detecting or quantifying the first analyte substance based on the emitted light measured in the step (G).

11.权利要求10所述的测定方法,其中,在所述测定仪器中,按照从所述第2试样供给口至所述试剂保持部的距离X与从所述第1试样供给口至所述电极的距离Y满足关系式X<Y的方式配置所述试剂保持部和所述电极;在所述工序(D)中检测所述电信号的变化,并基于所述检测来自动地进行所述工序(F)。11. The measuring method according to claim 10, wherein, in the measuring instrument, the distance X from the second sample supply port to the reagent holding part is the same as the distance X from the first sample supply port to the reagent holding part. arranging the reagent holding part and the electrodes so that the distance Y of the electrodes satisfies the relational expression X<Y; detecting the change of the electrical signal in the step (D), and automatically performing the process based on the detection; The process (F).

12.权利要求10所述的测定方法,其中,在所述测定仪器中,所述第1容器还具备空气孔,且所述第1试样供给口和所述第2试样供给口设置在相互邻接的位置上;在所述工序(D)中检测所述电信号的变化,并基于所述检测,在所述工序(B)中将所述试样通过所述第2试样供给口抽吸至所述第2容器的内部。12. The measuring method according to claim 10, wherein, in the measuring instrument, the first container is further provided with an air hole, and the first sample supply port and the second sample supply port are arranged at At positions adjacent to each other; detecting a change in the electrical signal in the step (D), and passing the sample through the second sample supply port in the step (B) based on the detection Aspirate to the inside of the second container.

13.权利要求1~5任一项所述的测定仪器,其中,所述第1容器和所述第2容器介由所述第2试样供给口来相互连通。13. The measuring instrument according to any one of claims 1 to 5, wherein the first container and the second container communicate with each other via the second sample supply port.

14.权利要求13所述的测定仪器,其还具备防止所述试样从所述第2容器通过所述第2试样供给口流向所述第1容器的阀。14. The measuring instrument according to claim 13, further comprising a valve that prevents the sample from flowing from the second container to the first container through the second sample supply port.

Claims (14)

1.用于分析试样中所含的待测物质的测定仪器,其具备:用于保持含有待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;1. A measuring instrument for analyzing a test substance contained in a sample, comprising: a first container and a second container for holding a sample containing the test substance; an optical measurement unit for optically measuring the sample in the container; 所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;The first container has a first sample supply port and an electrode for supplying the sample into the first container; 所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部。The second container includes a second sample supply port for supplying the sample into the second container, and a reagent holding portion for holding a reagent used for the optical measurement. 2.权利要求1所述的测定仪器,其中,所述光学测定部具备:用于使入射光从所述第2容器的外部入射到内部的光入射部;和用于使出射光从所述第2容器的内部射出到外部的光出射部。2. The measuring instrument according to claim 1, wherein the optical measuring unit has: a light incident unit for making incident light incident from the outside of the second container to the inside; The inside of the second container emits light to the outside of the light emitting portion. 3.权利要求1或2所述的测定仪器,其中,所述电极为一对电极。3. The measuring instrument according to claim 1 or 2, wherein the electrodes are a pair of electrodes. 4.权利要求1所述的测定仪器,其中,所述电极上附载有酶。4. The measurement device according to claim 1, wherein an enzyme is attached to the electrode. 5.权利要求1~4任一项所述的测定仪器,其中,所述试剂含有酶或抗体。5. The measurement device according to any one of claims 1 to 4, wherein the reagent contains an enzyme or an antibody. 6.权利要求1~5任一项所述的测定仪器,其中,按照从所述第2试样供给口至所述试剂保持部的距离X与从所述第1试样供给口至所述电极的距离Y满足关系式X<Y的方式配置所述试剂保持部和所述电极。6. The measuring instrument according to any one of claims 1 to 5, wherein the distance X from the second sample supply port to the reagent holding part is the same as the distance X from the first sample supply port to the reagent holding part. The reagent holding portion and the electrodes are arranged such that the distance Y between the electrodes satisfies the relational expression X<Y. 7.权利要求1~5任一项所述的测定仪器,其中,所述第1容器还具备空气孔。7. The measuring instrument according to any one of claims 1 to 5, wherein the first container further includes an air hole. 8.用于分析试样中所含的待测物质的测定装置,其具备:用于安装权利要求1~7任一项所述的测定仪器的测定仪器安装部;用于发出从所述第2容器的外部入射到内部的入射光的光源;用于接受从所述第2容器的内部射出到外部的出射光的受光部;用于对所述电极施加电压的电压施加部;用于对来自所述电极的电信号进行测定的电信号测定部;和用于基于通过所述受光部接受的所述出射光和通过所述电信号测定部测定的所述电信号中的至少一个来对所述试样中所含的所述待测物质进行检测或定量的运算部。8. A measuring device for analyzing a substance to be measured contained in a sample, comprising: a measuring device installation part for mounting the measuring device according to any one of claims 1 to 7; 2. A light source for incident light from the outside of the container to the inside; a light receiving unit for receiving light emitted from the inside of the second container to the outside; a voltage applying unit for applying a voltage to the electrodes; an electric signal measuring unit for measuring an electric signal from the electrode; and for measuring based on at least one of the outgoing light received by the light receiving unit and the electric signal measured by the electric signal measuring unit A computing unit for detecting or quantifying the analyte contained in the sample. 9.权利要求8所述的测定装置,其中,其还具备抽吸部,该抽吸部用于通过抽吸将所述试样供给至安装于所述测定仪器安装部的所述测定仪器的所述第1容器和所述第2容器中的至少一个。9. The measuring device according to claim 8, further comprising a suction unit for supplying the sample by suction to the measuring instrument attached to the measuring instrument mounting portion. At least one of the first container and the second container. 10.使用测定仪器对试样中所含的第1待测物质和第2待测物质进行测定的方法,其中,所述测定仪器具备:用于保持含有第1待测物质和第2待测物质的试样的第1容器和第2容器、以及用于对保持在所述第2容器内的所述试样进行光学测定的光学测定部;10. A method for measuring a first analyte and a second analyte contained in a sample using a measuring instrument, wherein the measuring instrument is equipped with a method for maintaining the first analyte and the second analyte a first container and a second container for a sample of a substance, and an optical measurement unit for optically measuring the sample held in the second container; 所述第1容器具备用于将所述试样供给至所述第1容器中的第1试样供给口和电极;The first container has a first sample supply port and an electrode for supplying the sample into the first container; 所述第2容器具备用于将所述试样供给至所述第2容器中的第2试样供给口和用来保持用于所述光学测定的试剂的试剂保持部,The second container includes a second sample supply port for supplying the sample into the second container and a reagent holding portion for holding a reagent for the optical measurement, 所述测定方法包含以下工序:The assay method comprises the following steps: (A)将所述试样通过浸渍于所述试样中的所述第1试样供给口供给至所述第1容器内的工序;(A) a step of supplying the sample into the first container through the first sample supply port immersed in the sample; (B)将所述试样通过浸渍于所述试样中的所述第2试样供给口供给至所述第2容器内的工序;(B) a step of supplying the sample into the second container through the second sample supply port immersed in the sample; (C)对所述电极施加电压的工序;(C) a step of applying a voltage to the electrodes; (D)对来自所述电极的电信号进行测定的工序;(D) a step of measuring electrical signals from the electrodes; (E)基于在所述工序(D)中测定的所述电信号来对所述第2待测物质进行检测或定量的工序;(E) a step of detecting or quantifying the second analyte based on the electrical signal measured in the step (D); (F)将入射光通过所述光学测定部照射到保持于所述第2容器内的所述试样上的工序;(F) a step of irradiating incident light onto the sample held in the second container through the optical measurement unit; (G)对由于所述入射光的照射而引起的从所述第2容器的内部通过所述光学测定部射出到外部的出射光进行测定的工序;(G) a step of measuring emitted light emitted from the inside of the second container through the optical measurement unit to the outside due to the irradiation of the incident light; (H)基于在所述工序(G)中测定的所述出射光来对所述第1待测物质进行检测或定量的工序。(H) A step of detecting or quantifying the first analyte substance based on the emitted light measured in the step (G). 11.权利要求10所述的测定方法,其中,在所述测定仪器中,按照从所述第2试样供给口至所述试剂保持部的距离X与从所述第1试样供给口至所述电极的距离Y满足关系式X<Y的方式配置所述试剂保持部和所述电极;在所述工序(D)中检测所述电信号的变化,并基于所述检测来自动地进行所述工序(F)。11. The measuring method according to claim 10, wherein, in the measuring instrument, the distance X from the second sample supply port to the reagent holding part is the same as the distance X from the first sample supply port to the reagent holding part. arranging the reagent holding part and the electrodes so that the distance Y of the electrodes satisfies the relational expression X<Y; detecting the change of the electrical signal in the step (D), and automatically performing the process based on the detection; The process (F). 12.权利要求10所述的测定方法,其中,在所述测定仪器中,所述第1容器还具备空气孔,且所述第1试样供给口和所述第2试样供给口设置在相互邻接的位置上;在所述工序(D)中检测所述电信号的变化,并基于所述检测,在所述工序(B)中将所述试样通过所述第2试样供给口抽吸至所述第2容器的内部。12. The measuring method according to claim 10, wherein, in the measuring instrument, the first container is further provided with an air hole, and the first sample supply port and the second sample supply port are arranged at At positions adjacent to each other; detecting a change in the electrical signal in the step (D), and passing the sample through the second sample supply port in the step (B) based on the detection Aspirate to the inside of the second container. 13.权利要求1~5任一项所述的测定仪器,其中,所述第1容器和所述第2容器介由所述第2试样供给口来相互连通。13. The measuring instrument according to any one of claims 1 to 5, wherein the first container and the second container communicate with each other via the second sample supply port. 14.权利要求13所述的测定仪器,其还具备防止所述试样从所述第2容器通过所述第2试样供给口流向所述第1容器的阀。14. The measuring instrument according to claim 13, further comprising a valve that prevents the sample from flowing from the second container to the first container through the second sample supply port.
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